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- 2025-12-20 01:13:42
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- LEO Pharma’s topical JAKi Anzupgo approved in KOR
- by Son, Hyung Min Sep 24, 2025 06:24am
- 레오파마 Global dermatology specialized pharmaceutical company LEO Pharma (General Manager Jung-Bum Shin) announced on the 23rd that its chronic hand eczema treatment Anzupgo (delgocitinib) was officially approved by the Ministry of Food and Drug Safety on the 8th. With the approval, adult patients in Korea suffering from moderate-to-severe chronic hand eczema (CHE) will now have access to a new treatment option that offers both efficacy and convenience. Chronic hand eczema is a multifactorial inflammatory skin disease characterized primarily by itching and pain, defined as eczema persisting for more than 3 months or recurring at least twice within a year. It is among the most common skin disorders affecting the hands, and a significant proportion of cases progress to chronic disease. Globally, CHE affects about 1 in 10 adults and can severely impair quality of life by imposing functional, occupational, and psychological burdens. Approximately 70% of patients with severe CHE struggle with daily activities, which directly affects their employment and income. Anzupgo is the only non-steroidal topical cream formulation approved for adult patients with moderate-to-severe CHE who do not respond to or are unsuitable for topical corticosteroids. The product contains no parabens or steroids and works by inhibiting the JAK-STAT signaling pathway involved in various inflammatory responses. By blocking the activity of JAK1, 2, 3, and TYK2, the drug helps reduce skin inflammation and itching. Multiple clinical trials have demonstrated broad efficacy across all subtypes of moderate-to-severe CHE. Until now, treatment options for CHE have been limited, with strong topical corticosteroids used most frequently. However, long-term use carries risks such as skin barrier damage, atrophy, and telangiectasias. Due to this reason, in cases that show insufficient short-term improvement, guidelines have recommended combining topical calcineurin inhibitors or systemic corticosteroids. Currently, the only approved oral therapy for severe chronic hand eczema is alitretinoin, used for patients unresponsive to at least 4 weeks of potent topical corticosteroids. It improves symptoms through skin regulation, anti-inflammatory, and immunomodulatory actions, and is known to be effective for the long-term management of chronic severe hand eczema with a high risk of recurrence. However, its use has been constrained by risks including hepatotoxicity, thyroid dysfunction, dyslipidemia, and teratogenicity. In the head-to-head DELTA FORCE trial that directly compared oral alitretinoin with Anzupgo, the Anzupgo group achieved a statistically superior improvement in HECSI scores at week 12 (-67.6). It also demonstrated higher achievement rates in HECSI-90 and IGA-CHE TS (score 0/1). Over the 24-week treatment period, Anzupgo showed a better safety profile and lower incidence of adverse events compared to alitretinoin, confirming both strong efficacy and good tolerability. Jung-Bum Shin, General Manager of LEO Pharma Korea, stated: “Chronic hand eczema not only causes physical suffering but also serious social and emotional challenges. We are pleased to be able to provide the much-needed treatment option, Anzupgo, in Korea with its approval.” Shin added, “We will do our best to ensure Anzupgo contributes to changing the treatment paradigm for chronic hand eczema and improving patients’ quality of life in Korea.” LEO Pharma has been continuing the global launch of Anzupgo, having secured official approval in Korea following approvals in Europe, the UK, Switzerland, the UAE, Canada, Australia, and the US.
- Policy
- Contraindication guidelines to flu vaccine cut down in KOR
- by Lee, Tak-Sun Sep 23, 2025 06:07am
- The Ministry of Food and Drug Safety (MFDS) plans to significantly reduce the list of contraindications for influenza (flu) vaccines. The MFDS has decided to create a new set of recommended guidelines because the previous contraindications were deemed inconsistent with current clinical practice and international standards. The MFDS collected public opinion on the recommended guidelines for contraindications and precautions for inactivated influenza vaccines until September 19. Most flu vaccines are inactivated vaccines (made from killed viruses). The new recommendations reduced the number of contraindications to two: ▲Individuals with a severe hypersensitivity reaction to any of the vaccine's components (active ingredients and excipients) or to egg ingredients (ovalbumin, egg protein), formaldehyde, or polysorbate ▲Individuals who have previously had a severe hypersensitivity reaction (e.g., anaphylaxis) to an influenza vaccine. In addition to contraindications, a new category for cautious administration group was also established. This category includes three key points: ▲Caution should be exercised when administering intramuscular injections to individuals with thrombocytopenia or coagulation disorders, as bleeding may occur ▲For individuals who have a history of developing Guillain-Barre syndrome or other neurological disorders within six weeks of a previous influenza vaccination, the benefits and risks of vaccination should be carefully considered ▲Vaccination should be postponed for individuals with a severe febrile illness or acute illness. According to the current vaccination approval, the listed contraindications are over 10, where items may vary. For example, ▲Individuals with fever or severe malnutrition ▲Patients with cardiovascular diseases, kidney disease or liver disease whose disease states are in aggressive state, middle state, or active state ▲Patients with acute respiratory disease or active infectious disease. However, in clinical practice, these patient groups, particularly those with chronic diseases, are strongly encouraged to get vaccinated. The MFDS official explained, "The influenza vaccines were approved a long time ago, so they don't align with today's reality or international standards. This is why we have prepared these new recommendations." The new recommendations were established at the request of pharmaceutical companies. Meanwhile, approximately 28 million doses of flu vaccine are scheduled to be supplied in the second half of this year. Seven domestically manufactured products, including those from companies such as Green Cross and SK Bioscience, as well as seven imported products from companies like GSK and Sanofi, will be available. Sanofi announced that it has been supplying its trivalent flu vaccine, 'Vaxigrip,' nationwide since September 3.
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- Sanofi begins nationwide supply of flu vaccine Vaxigrip
- by Son, Hyung Min Sep 23, 2025 06:07am
- Sanofi announced on the 22nd that it has begun nationwide supply of its trivalent influenza vaccine Vaxigrip from September 3rd, ahead of the 2025–2026 flu vaccination season. According to the Korea Disease Control and Prevention Agency’s analysis of influenza surveillance results for the 2024–2025 season, last year’s flu epidemic began later than the previous year, peaking in early January 2025. However, the scale of the epidemic was 20–30% greater than the year before and was the highest level since 2016. In particular, a secondary outbreak occurred among school-aged children and adolescents after the winter break, while prevalence also expanded among middle-aged adults, and those aged 65 and older increased about 20% compared with the 2023–2024 season. Considering these trends, large-scale epidemics could repeat in the upcoming season, highlighting the need for early vaccination. Influenza is more than just a respiratory disease; it can lead to severe complications such as worsening of underlying conditions, pneumonia, and cardiovascular deterioration. In particular, high-risk groups—infants and young children, pregnant women, patients with chronic conditions, and the elderly—face higher risks of hospitalization, severe complications, and death following infection, requiring particular attention. Sanofi is the only imported vaccine manufacturer that has participated in Korea’s National Immunization Program (NIP) for 4 consecutive years. This year’s supply of Vaxigrip is available at public health centers, contracted medical institutions, and major hospitals and clinics nationwide. Beginning this year, Korea’s NIP flu vaccine program shifted from quadrivalent to trivalent formulations, and Sanofi secured rapid approval and distribution to provide vaccines in a timely manner. Vaxigrip is a finished imported vaccine supplied domestically by Sanofi, a company with over 100 years of vaccine development history, which manufactures it in France in its entirety, from bulk solution to packaging. The vaccine’s immunogenicity and safety profile have been confirmed through 6 large-scale global clinical trials across four continents (Europe, Asia, South America, and Oceania), which enrolled more than 13,000 participants, including children, patients with underlying conditions, and the elderly. ▲Efficacy in reducing influenza-related complications was confirmed in infants and young children aged 6 to 35 months in one trial, and ▲ in another trial targeting only coronary artery disease patients, efficacy in preventing cardiovascular disease complications was confirmed. Furthermore, ▲consistent preventive efficacy and safety profiles were confirmed across all age groups, including high-risk populations, as demonstrated by a clinical trial confirming vaccine effectiveness and safe use in pregnant women. Together, these results establish consistent preventive efficacy and safety across all age groups, including high-risk populations. According to related studies, using a flu vaccine that precisely matches the viral antigens circulating during that season can prevent hospitalizations or deaths from influenza or pneumonia in patients with chronic conditions such as diabetes, heart disease, or lung disease by approximately 43-56%. Furthermore, in a clinical trial specifically targeting patients with coronary artery disease, vaccination in patients with myocardial infarction or high-risk coronary artery disease reduced the combined risk of all-cause mortality and myocardial infarction or stent thrombosis by 28%. It also reduced the risk of all-cause mortality and the risk of death from cardiovascular events by 41% each.
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- ‘Reimb needed for Ozempic, a powerful weapon for diabetes’
- by Hwang, byoung woo Sep 23, 2025 06:07am
- Diabetes treatment has moved beyond blood glucose control and entered the era of “personalized strategies,” With the Korean Diabetes Association’s 2025 clinical guidelines removing the long-standing recommendation of metformin as the first-line therapy and instead advising initial treatment based on patient characteristics and comorbidities, attention is now turning to the need for reimbursement of GLP-1RA therapy Ozempic (semaglutide). During an interview with Dailypharm, Professor Choi Sung-Hee, Director of Public Relations for the Korean Diabetes Association and professor at Seoul National University Bundang Hospital, stressed the importance of insurance policies in enabling treatment strategies tailored to individual patient needs. KDA revises guidelines and opens the era of personalized care The 2025 revised guidelines of the Korean Diabetes Association boldly removed the recommendation of metformin as the first-line therapy, which had long been considered the standard, shifting instead toward patient-centered, personalized treatment. Sung-Hee Choi, Professor of Endocrinology and Metabolism, Seoul National University Bundang HospitalThe revision goes beyond simple glucose control to include consideration of comorbidities (cardiovascular and renal) through a personalized treatment approach. In other words, it is no longer necessary to always start with metformin; the doctor may consider combination therapy from the outset according to the patient’s condition and clinical profile. Professor Choi explained, “Diabetes patients present in highly diverse situations, and some cannot tolerate metformin well. Depending on individual conditions such as impaired kidney function or obesity, it may not be necessary to use metformin first, and in severe cases, combination therapy could be considered from the beginning,” highlighting the flexibility of the new guidelines. Professor Choi added that in actual clinical practice, some patients cannot take metformin, and depending on comorbidities such as impaired kidney function, heart failure, or severe obesity, GLP-1 receptor agonists or SGLT2 inhibitors have already been emerging as first-line options. The KDA has sought to move away from a purely glucose-lowering focus, pushing for a paradigm shift toward comprehensive management of comorbidities such as hypertension and dyslipidemia. Professor Choi stated, “For patients with impaired renal function, heart failure, or obesity/severe obesity, the role and clinical value of GLP-1RAs and SGLT2 inhibitors are becoming increasingly significant. This guideline revision carries significant implications for diabetic patients with such complications.” The treatment paradigm is being reshaped to meet the increasing incidence of obesity-related diabetes. Professor Choi cited the publication of the Diabetes & Obesity Fact Sheet as an example, underscoring the seriousness of obesity in younger generations. In particular, the number of obese diabetes patients in their 20s to 40s is rapidly increasing, with the obesity rate among young men being especially pronounced. Professor Choi explained, “The key to realizing personalized treatment is early detection and proactive management of high-risk patients. Since semaglutide-based anti-obesity drugs, which can simultaneously manage diabetes and obesity, were derived from diabetes treatments, early intervention to control obesity is the key to preventing chronic complications.” Ozempic's value verified through clinical evidence...“Expect it to benefit obese diabetics” Against this backdrop of rising obesity-related diabetes, the role of Ozempic (semaglutide) is gaining attention. Professor Choi said, “Ozempic is a viable option for obese diabetic patients. While existing therapies have shown limited weight loss effects in this group, Ozempic excels not only in lowering blood glucose but also in promoting significant weight reduction.” Indeed, across the SUSTAIN trial series (phases 1–9), Ozempic significantly improved HbA1c and body weight compared to DPP-4 inhibitors, sulfonylureas, other GLP-1 analogs, and even insulin. “Ozempic-based regimens have consistently outperformed traditional combinations in obese diabetic patients, and this has been demonstrated in multiple studies. Furthermore, the recently published FLOW trial was particularly impressive, as it confirmed with large-scale clinical data the kidney-protective effects of GLP-1RAs that had previously only been hypothesized.” The FLOW study directly focused on kidney function and found that Ozempic reduced the rate of decline in estimated glomerular filtration rate (eGFR) and the progression to end-stage renal disease (ESRD) by approximately 24%. She further highlighted the strengths of Ozempic in diabetic patients at high risk of atherosclerotic cardiovascular disease. “Diabetic patients with obesity or severe obesity face very high risks of atherosclerotic cardiovascular events. Ozempic has robust clinical data across this area,” she said. “For diabetic patients with still unmet medical needs, such as obesity and cardiovascular disease, Ozempic represents a powerful new weapon.” Accessibility remains a hurdle due to non-covered status… Emphasis on the need for reimbursement without restrictions Ozempic is currently approved in Korea as a diabetes treatment but remains non-reimbursed. Consequently, regardless of the drug's efficacy, a significant cost burden persists. Professor Choi said, “Reimbursement for Ozempic in type 2 diabetes is essential. Most patients cannot afford to use it without reimbursement. While obesity is important, in diabetic patients, Ozempic must enter the reimbursement framework, and reimbursement criteria must allow combination therapy with diverse agents.” Novo Nordisk Korea reapplied for reimbursement of Ozempic in the first half of 2025. Its insurance price has been agreed with the Health Insurance Review and Assessment Service in earlier negotiations; the final talks collapsed due to supply instability last time, raising hopes for a more favorable outcome this time. Regarding the reimbursement discussion for Ozempic, Professor Choi emphasized that reimbursement criteria should not impose restrictions to ensure personalized treatment for diabetes patients. Currently, even with dulaglutide, the only GLO-1RA class drug granted reimbursement, there are limitations, as it can only be combined with metformin or sulfonylureas under reimbursement. The opinion is that, after Ozempic becomes reimbursed, to achieve sufficient efficacy, an environment must be established where it can be freely combined with existing diabetes medications to see additional benefits, and then treatment can proceed by gradually reducing the number of combination drugs based on the patient's situation. “In hypertension, up to four drugs are commonly combined, but in diabetes, combination is usually limited to two, which is highly restrictive. At minimum, Ozempic must be allowed use in combination with standard oral agents such as DPP-4 inhibitors and SGLT2 inhibitors.” Professor Choi further noted, “While it is important to begin reimbursement under criteria similar to those of existing drugs in the same class, the real goal should be enabling broader combination therapy aligned with Ozempic’s evidence base. This approach will maximize therapeutic benefit.” Concluding the interview, Prof. Choi reiterated, “Diabetes is not merely a condition of elevated blood sugar, but a complex disease entangled with multiple metabolic complications.” “Based on diverse research findings, healthcare providers should be able to combine treatments with sufficient evidence, and if it aligns with guidelines, insurance should support various treatment options. Going forward, if there is sufficient scientific evidence, the government and pharmaceutical companies should engage in more bold negotiations to ensure domestic patients can benefit from advanced treatments.”
- Policy
- Will access to aHUS drugs improve in Korea?
- by Jung, Heung-Jun Sep 23, 2025 06:06am
- The prior approval criteria for receiving reimbursement of atypical hemolytic uremic syndrome (aHUS) drugs, which had long been criticized for impeding patient access, have been improved. This issue was raised during last year’s National Assembly audit as well. At that time, Rep. Yoon Kim (Democratic Party of Korea) pointed out the low approval rate for Soliris (eculizumab). With approval rates hovering at only 30–40% annually, patient access was significantly limited, leading to calls for easing the pre-approval requirements. The Ministry of Health and Welfare (MOHW) is currently collecting public opinion on the proposed partial amendment to the ‘Detailed Rules on the Standards and Methods for Applying Health Insurance Benefits (Drugs),’ from September 18 to 22. The revised proposal specifies the criteria for insurance reimbursement and relaxes or adds detailed requirements on hemoglobin and haptoglobin levels, etc. Previously, the reimbursement criteria required meeting all of the following: ▲ Platelet count below the lower limit of normal at the institution, ▲Presence of schistocytes, ▲ Hemoglobin < 10 g/dL, ▲and Lactate dehydrogenase (LDH) ≥ 1.5 times the upper limit of normal. The revised criteria are as follows: ▲Platelet count < 150×10⁹/L, ▲ Presence of schistocytes, ▲ Hemoglobin < 12 g/dL (or < 11 g/dL for children under 5), ▲ LDH above the upper limit of normal, ▲Haptoglobin below the lower limit of normal. For renal impairment, the wording was changed from “patients” to “cases,” but the thresholds remain the same: ▲≥20% decline in eGFR, ▲Serum creatinine above the age- and sex-specific upper limit of normal. The ADAMTS-13 testing requirement was also specified. Tests must be conducted before plasma exchange or plasma infusion, before the 4th treatment session, or at least 7 days after stopping treatment. However, the criterion based on serum creatinine levels was removed. In addition, a new criterion was added to allow reimbursement even if other requirements were not met. Specifically, if end-stage renal disease due to aHUS is suspected and the drug is required before or after kidney transplantation, coverage may be granted on a case-by-case basis. In addition, the following conditions were removed from the exclusion criteria: ▲ Hemolytic uremic syndrome caused by Shiga toxin, ▲Transplantation, ▲Fibrin thrombosis, ▲paroxysmal nocturnal hemoglobinuria, catastrophic hyperlipoproteinemia, ▲ Sepsis, ▲and other secondary hemolytic uremic syndromes. The revised proposal applies identical detailed recognition criteria to eculizumab (Soliris) and ravulizumab (Ultomiris). The MOHW plans to implement the revised criteria starting October 1, after completing the public opinion collection period.
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- Bylvay successfully obtains reimbursement on the 2nd attempt
- by Moon, sung-ho Sep 23, 2025 06:06am
- Bylvay (odeviksibab), a treatment for Progressive Familial Intrahepatic Cholestasis (PFIC), will be included in the National Health Insurance reimbursement program starting next month. As a high-cost medication for a severe and rare disease, Bylvay's reimbursement and monitoring have been categorized under government management. According to industry sources on September 22, the Ministry of Health and Welfare recently issued an administrative pre-announcement for a revision to the 'Detailed Standards for the Application and Methods of Health Reimbursement Benefits,' which includes reimbursement for Ipsen Korea's Bylvay. If there are no major objections, this drug can be reimbursed from October. PFIC is a rare genetic disorder where the accumulation of bile acids in the liver causes damage and can lead to liver failure. It is a serious condition that may require a liver transplant if not diagnosed and managed effectively early on. A key symptom of the disease, pruritus, significantly impacts sleep and daily activities, leading to skin damage, sleep loss, irritability, and reduced attention. Ipsen Korea has estimated that the treatment applies to approximately 50 patients, highlighting the rarity of the disease. Due to the severity of PFIC and the innovative nature of the drug with few alternatives, Bylvay was selected as the first drug in the Concurrent Approval-Evaluation-Negotiation Pilot Program initiated by the Ministry of Health and Welfare in 2023 to accelerate the introduction of innovative new drugs. However, the reimbursement process was not easy. Bylvay went through a 're-evaluation' at the Health Insurance Review & Assessment Service's (HIRA) Drug Reimbursement Evaluation Committee (DREC). Due to the drug's status as a treatment for a rare disease and Ipsen Korea's firm resolve, Bylvay has been included in the reimbursement list in October. The Ministry of Health and Welfare selected Bylvay as a target for managing reimbursement of high-cost drugs. High-cost drugs are defined as 'medications that require price management and long-term efficacy verification due to their high cost and uncertain efficacy, or medications that require usage management due to their significant financial impact.' With the inclusion of Bylvay, the total number of managed treatments has increased to seven. Accordingly, the Ministry of Health and Welfare's policy is to approve an additional six months of administration if the treatment response criteria are met at the six-month evaluation after the first dose of Bylvay. After that, the patient will be re-evaluated every six months, and continued administration will be approved if the treatment response is maintained. The ministry also plans to approve reimbursement for patients who have been receiving Bylvay on a non-reimbursed basis, including through the pharmaceutical company's free supply program, after an evaluation. Specifically, if the reimbursement application is made within six months of the first dose, reimbursement will be approved if the patient's eligibility is confirmed in their medical records. If the reimbursement is applied for more than six months after the first dose, reimbursement will be approved if the patient's eligibility is confirmed in their medical records and their serum bile acid (sBA) concentration has decreased by 30% or more from baseline in the most recent response evaluation. If the sBA concentration has not reduced by 30% or more, reimbursement may still be approved if there is an improvement in pruritus (a CGIS score of 1 or less, or a decrease of 1 point or more from baseline). However, the most recent response evaluation must have been conducted within six months of the date the reimbursement application was submitted. The Ministry of Health and Welfare stated, "If a patient is eligible for treatment, administration for six months will be approved based on the most recent response evaluation. After that, the patient will be evaluated every six months, and continued administration will be approved if the treatment response meets the evaluation criteria." Meanwhile, Ipsen Korea is also expanding its influence in the clinical setting in Korea. In addition to securing reimbursement for Bylvay, the company recently obtained domestic approval for its primary biliary cholangitis (PBC) treatment, 'Iqirvo (elafibranor).' Ipsen Korea CEO Yang Mi-sun explained, "Bylvay is a treatment for PFIC, an ultra-rare disease that is very rarely caused by a failure of bile secretion," and added, "In the past, there were no suitable treatments, and in most cases, a liver transplant was necessary." Yang also said, "The fact that a patient must give a liver transplant to their child is something that I cannot take lightly. In this situation, Ipsen providing the first effective treatment option is very significant," and added, "PBC is also a disease that has been known for a long time but has lacked a suitable treatment. Therefore, we plan to redefine the approach to treating this disease together with experts in academia."
- Company
- Rising childhood obesity in Korea’s limited environment
- by Eo, Yun-Ho Sep 22, 2025 06:11am
- The need for active management of childhood and adolescent obesity is becoming increasingly emphasized, along with growing interest in the appropriate use of pharmacotherapy. According to the ‘2020 Clinical Practice Guidelines of the Korean Society for the Study of Obesity,’ childhood obesity treatment in Korea primarily focuses on lifestyle modification—including diet, exercise, and behavioral therapy—to maintain appropriate weight. However, when weight continues to increase and comorbidities remain uncontrolled, pharmacological and surgical therapies are recommended along with lifestyle modification. Currently, pharmacological treatment for obese adolescents aged 12 or older is applied very selectively, taking into account both obesity status and growth stage. Medications are recommended in cases such as ▲ adolescents with severe obesity accompanied by complications, ▲ those with a family history of cardiometabolic diseases such as type 2 diabetes, or ▲ those whose weight or complications cannot be controlled despite intensive diet and behavioral therapy. Recommended drugs include GLP-1 receptor agonists such as Saxenda (liraglutide) and Wegovy (semaglutide), the fat absorption inhibitor Xenical (orlistat), and the appetite suppressant combination Qsymia (phentermine/topiramate). ◆Obesity patients in need of pharmacotherapy increase among children and adolescents Following the outbreak of COVID-19 in 2020, school attendance and outdoor activities were restricted, leading to decreased physical activity compared to pre-pandemic levels and accelerating the spread of obesity among adolescents. Like adult obesity, childhood obesity is associated with a range of comorbidities, including hypertension, dyslipidemia, type 2 diabetes, non-alcoholic fatty liver disease, obstructive sleep apnea, polycystic ovary syndrome, and mental health disorders such as depression. In children with severe obesity, even more serious cardiometabolic diseases than myocardial infarction or arteriosclerosis have been reported. As a general principle, obesity treatment aims for about 10% weight reduction and maintenance. However, due to the rebound yo-yo effect, one-third to two-thirds of the lost weight is typically regained within one year, and over 95% is regained within 5 years. Therefore, if non-pharmacological interventions such as diet and exercise fail to achieve more than 5% weight reduction after 3–6 months, active pharmacotherapy should be considered. If no meaningful weight loss of at least 5% occurs within 3 months of medication use, a new treatment strategy should be planned. Ultimately, lifestyle modification remains the first-line treatment for childhood obesity. However, for patients who fail to achieve weight loss through this approach, pharmacotherapy may be the best option before considering bariatric surgery. Candidates for obesity pharmacotherapy include those with a BMI above the 95th percentile and weight-related comorbidities, or those with a BMI at least 120% of the 95th percentile, regardless of comorbidity status, who do not respond adequately to lifestyle modification. Specifically, the proportion of obese children and adolescents in Korea requiring pharmacological treatment is currently estimated at 2–3%, and is expected to gradually reach below 5% due to dietary and lifestyle changes. ◆Limited pharmacotherapy options and considerations regarding Qsymia The problem is that, unlike abroad, the range of obesity treatments available in Korea is highly limited. Officially, the only drugs approved for use in children and adolescents aged 12 and above are Xenical and Saxenda. Xenical reduces fat absorption in the body. Despite the convenience of being an oral medication, it is used only sparingly due to common side effects such as diarrhea, abdominal pain, and increased intestinal gas. In addition, because it reduces absorption of fat-soluble vitamins, patients must take a daily multivitamin containing these nutrients. The American Gastroenterological Association (AGA) even recommended against using Xenical in its 2022 clinical practice guidelines on pharmacological interventions for adult obesity, citing these adverse effects. Qsymia can be prescribed to children and adolescents in the U.S., but it is not approved in Korea because one of its components, phentermine, is contraindicated for use in patients under 16. However, Qsymia—a combination that contains topiramate—enhances anti-obesity effects while lowering the dosage of each component compared to monotherapy, thereby reducing side effects. It also has the advantage of requiring only once-daily administration, regardless of meals. Concerns about pediatric prescription mainly stem from safety, but accumulating research data continues to address this issue. Clinical pharmacology trials comparing phentermine and topiramate in adults versus adolescents have shown no significant differences in efficacy or safety between the two groups. The studies found that both agents exhibited similar pharmacokinetic characteristics in adolescents and adults. The type, frequency, and severity of adverse drug reactions, as well as discontinuation rates due to adverse events, were also comparable, indicating no major differences in safety or tolerability between the two groups. Professor Seung-Hwan Lee of Seoul National University Hospital’s Department of Clinical Pharmacology stated, “The dose–pharmacokinetic–pharmacodynamic–clinical response relationships for phentermine and topiramate are similar in adolescents and adults. Therefore, the same dosage and regimen can be applied to adolescents as in adults. The adverse reactions are generally not severe and can be managed through dose reduction or discontinuation.”
- Company
- "Long-term survival possible for urothelial carcinoma"
- by Son, Hyung Min Sep 22, 2025 06:11am
- The treatment landscape for urothelial carcinoma is changing rapidly. Various approaches, including immunotherapy, antibody-drug conjugates (ADCs), and chemotherapy combination therapies, have been introduced. However, significant reimbursement barriers still exist in clinical practice. Among these, Merck's Bavencio (avelumab) is the only first-line maintenance treatment with insurance reimbursement applied in Korea. This drug has been a key treatment regimen of the long-term treatment strategy. In the JAVELIN Bladder 100 study, the basis of approval, Bavencio more than doubled overall survival (OS) compared to the prior standard of care, presenting a new paradigm that moved beyond a 'watch-and-wait' strategy. The latest real-world data (RWD) confirmed the clinical study, strengthening Bavencio's reliability in actual treatment settings. With most urothelial carcinoma patients being older adults, cost-effectiveness and safety are crucial for long-term treatment strategies. Experts' main opinion is that Bavencio is a treatment that satisfies both conditions simultaneously. DailyPharm met with Professor In Ho Kim of Seoul St. Mary's Hospital's Department of Medical Oncology and Professor Hongsik Kim of Chungbuk National University Hospital's Department of Hematology and Oncology to discuss the changes in the urothelial carcinoma treatment landscape and the reasons why the focus should be on long-term treatment strategies beyond just survival. Long-term survival effect confirmed by real-world data Both experts cited the consistent results of Bavencio, as demonstrated in RWD, as its greatest strength. RWD from multi-national studies, including the Japanese JAVEMACS, U.S. PATRIOT-II, and French AVENANCE trials, showed a median OS for Bavencio of over 30 months, with some analyses reporting extended results of over 40 months. Notably, a treatment strategy that continues with an ADC (such as enfortumab vedotin) after first-line Bavencio maintenance treatment has been reported to show an OS of over 41 months, substantially expanding the possibility of long-term survival for patients. Professor In Ho Kim of Seoul St. MaryProfessor Kim said, "In a clinical practice, it's very rare for a patient not to undergo Bavencio maintenance treatment. Except for a few patients who have difficulty adapting to immunotherapy, most are being treated with Bavencio maintenance therapy." Professor Kim added, "It is difficult for clinical trial data to become part of actual patient care, but Bavencio is an exception. The results from the clinical setting and the real world are almost identical." He assessed that "this drug provides a foundation for patients to continue treatment for a long time without difficulty." Professor Kim emphasized, "Because Bavencio has only a few side effects, it allows patients to continue therapy. Since patients feel comfortable with Bavencio maintenance treatment, long-term treatment is possible," and noted, "In clinical practice, patients are often in poorer health or are older than those in clinical trials, so we believe Bavencio's biggest advantage is that it can be used to treat these patients without difficulty." Data from Korea also supported these findings. An analysis of an Expanded Access Program (EAP) involving 30 patients from five Korean hospitals from 2021 to 2023 showed a median progression-free survival (PFS) of 7.9 months from the start of Bavencio, surpassing the 5.5 months in the JAVELIN Bladder 100 study. The complete response (CR) rate was 20%, and the median duration of CR reached 17.8 months. The fact that the results were consistent with global outcomes despite unfavorable conditions, 67% of patients were Stage 4 at diagnosis, and 40% had visceral metastasis, is highly significant. This also serves as the reason why Bavencio quickly became the standard of care for first-line maintenance therapy for urothelial carcinoma after its reimbursement application. Professor Kim said, "Clinical trials mainly include young, healthy patients, but in real-world practice, the majority of patients are older adults, with an average age of over 70." He added, "It is significant that the same survival curve appeared in this patient population as in the clinical trials." And he added, "Because Bavencio has few side effects, even patients in their mid-80s can use it without burden. When patients transition from platinum-based chemotherapy to Bavencio maintenance treatment, most see their condition improve after treatment, allowing them to proceed to second-line treatment, and there are many cases of long-term survival. The positive results confirmed in clinical trials are being directly translated into patient treatment." Professor Kim also mentioned, "In clinical settings, the effect was maintained even in patients with chronic kidney disease who were on dialysis. It has been confirmed that Bavencio maintenance treatment significantly improved patients' quality of life." First-line maintenance treatment as a practical alternative to reimbursement barriers While the number of urothelial carcinoma patients is steadily increasing in Korea, the treatment environment remains challenging. The recurrence rate after platinum-based chemotherapy is high, and immunotherapy as a monotherapy is not guaranteed to extend survival in the long term. Currently, various options are available for first-line urothelial carcinoma treatment. For example, combination therapies with immunotherapy and ADCs, as well as combination therapy with nivolumab + GemCis (gemcitabine + cisplatin). However, the ADC combination therapy is not covered by reimbursement, and the nivolumab and GemCis combination therapy is only reimbursed for a limited number of drugs. Bavencio maintenance therapy is currently the only option with reimbursement in Korea and is the most widely used in real-world clinical practice. Professor Hongsik Kim of Chungbuk National University HospitalProfessor Kim said, "Because I work at a regional hospital, I prioritize minimizing the financial burden on patients. I prefer treatments that are covered by reimbursement for long-term use. Consequently, we most often use gemcitabine-based platinum chemotherapy, followed by Bavencio maintenance treatment. If the disease progresses after Bavencio maintenance therapy, we use treatments like paclitaxel." He added, "On the other hand, for treatments like ADC, there isn't enough long-term sequencing data. Among the treatments currently used for urothelial carcinoma, Bavencio has the most abundant sequencing data, which provides a foundation for patients to receive stable Bavencio maintenance therapy for a long time in a clinical setting." The experts commonly pointed out that the future treatment paradigm should shift beyond simple life extension to a 'long-term treatment strategy.' Professor Kim explained, "What is particularly noteworthy in the urothelial carcinoma treatment landscape is that the number of second-line and later treatment options has increased significantly compared to the past. While immunotherapy monotherapy dominated in the past, a variety of new treatments have emerged, giving patients many more choices. I think this is a very fortunate change in the clinical setting." He continued, "With other immunotherapies and new drug candidates accumulating clinical evidence, a reimbursed first-line maintenance therapy is the most practical alternative for patients. Like other immunotherapies, Bavencio has a two-year limit on reimbursement. This drug can be administered for a long time until intolerance occurs. I understand the intent of the system, but since many patients remain stable for more than two years, I believe a separate discussion is needed based on individual patient circumstances." Finally, Professor Kim added, "Since Bavencio became reimbursed, many patients have had fewer worries during their treatment. Patients often place more value on a treatment-providing environment than on the drug itself. While various new drugs are being developed, I believe Bavencio will continue to play an important role in the urothelial carcinoma treatment."
- Company
- NMOSD patients call for Ultomiris’s reimbursement
- by Hwang, byoung woo Sep 22, 2025 06:11am
- With the emergence of an innovative treatment option for neuromyelitis optica spectrum disorder (NMOSD), a disease in which even one relapse can cause a dramatic decline in quality of life, voices are growing for improved access. Specifically, voices are rising on the need to improve access to Ultomiris (ravulizumab), which has demonstrated a relapse-free period of 73.5 weeks in a clinical trial, as a paradigm-shifting therapy to overcome the limitations of existing treatments. Need for treatment approaches focused on “relapse prevention” highlighted in NMOSD NMOSD is a central nervous system autoimmune disorder that causes nerve damage, primarily presenting with optic neuritis and myelitis. More than 90% of patients experience relapses. Neuromyelitis optica spectrum disorder (NMOSD) can lead to cumulative nerve damage with repeated relapses, potentially resulting in lower body paralysis or blindness.Repeated relapses lead to cumulative nerve damage, resulting in symptoms such as ocular pain, vision loss, spinal or limb pain, muscle weakness, gait disturbance, and sensory-motor impairment of the lower body, which may progress to paraplegia or blindness. NMOSD occurs most frequently in women in their 30s and 40s, an age group typically active in the workforce, leading to social isolation caused by employment discontinuation, reduced interpersonal interactions, and limited activity. This has negative repercussions not only on the individual but also on families and society as a whole. For example, patient A first experienced symptoms around the age of 16, but it took 5 years to receive an accurate NMOSD diagnosis. By then, despite devoting herself to treatment, the aftereffects of frequent relapses left her with significant daily limitations. She is currently being treated with MabThera (rituximab), but side effects make even basic tasks such as eating and walking difficult without family assistance. Long-term immunosuppressive therapy has also weakened her immunity, making her prone to colds, pneumonia, and enteritis, and at times she has faced emergencies such as breathing difficulties and shock. In NMOSD treatment, the key is to block relapses at an early stage. Experts in Korea and abroad emphasize that because even a single relapse can cause irreversible damage, treatment approaches aimed at preventing relapse itself are critical. Ultomiris demonstrates “relapse-free” effect in NMOSD Against this backdrop, the next-generation C5 complement inhibitor Ultomiris has gained attention as an innovative therapy, confirming relapse-free efficacy in a Phase III trial with NMOSD patients. By improving its half-life, the drug overcomes limitations of previous therapies, and among 58 patients in the Ultomiris group, the relapse rate during the trial period was 0%, suggesting a paradigm shift in NMOSD treatment. Pic of Ultomiris In the Phase III CHAMPION-NMOSD study, Ultomiris showed no relapses during a median treatment period of 73.5 weeks and reduced relapse risk by 98.6% compared to placebo. Dosing intervals are also noteworthy: Ultomiris can be administered every 8 weeks, significantly reducing treatment burden compared to Soliris, which requires dosing every 2 weeks. Professor Ho-Jin Kim from the Department of Neurology at the National Cancer Center explained, “The extended dosing interval not only reduces hospital visits, it also lowers physical strain and additional costs associated with travel for patients with impaired mobility and vision. Such improvements in treatment convenience can enhance patients’ quality of life and adherence to therapy.” However, the fact that Ultomiris is yet to be reimbursed in Korea limits actual treatment access. Accordingly, both clinical experts and the Korean NMOSD Patient Association are increasingly calling for guaranteed access to proven therapies. Patient A said, “I live with daily anxiety, never knowing when a relapse will strike. I know there is a therapy that prevents relapses, but cannot try it because it is not reimbursed.” Meanwhile, to promote proper understanding and social awareness of NMOSD, a “Stay ZERO” concert will be held on September 25 at the National Assembly Member Office Building. The event aims to amplify the voices of patients longing for a “relapse-free life,” raise awareness of the importance of relapse-prevention treatment, and emphasize the need for improved treatment accessibility.
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- Reimb discussions begin for No.2 GIFT drug Nefecon
- by Eo, Yun-Ho Sep 22, 2025 06:10am
- Reimbursement discussions have begun for Nefecon (budesonide), the second drug designated under Korea’s GIFT (Global Innovative products on Fast Track) program and the first treatment for IgA nephropathy. According to industry sources, the Health Insurance Review and Assessment Service (HIRA) is expected to soon begin evaluation of the reimbursement application submitted late last year by Everest Medicines Korea. The specific indication under review is “treatment of adult patients with primary IgA nephropathy (immunoglobulin A nephropathy, IgAN) who have a proteinuria level of ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.8 g/g).” Nefecon was designated as the second GIFT drug by the Ministry of Food and Drug Safety (MFDS) in November 2024. With GIFT No. 1, Bylvay (odevixibat), essentially granted reimbursement, attention is now gathering on whether Nefecon will also be added to the reimbursement list. IgA nephropathy is an autoimmune glomerulonephritis in which immune complexes deposit in the glomeruli, causing chronic inflammation and kidney damage. Among severe patients with high proteinuria and low glomerular filtration rate, approximately 50% progress to ESRD (end-stage renal disease) or death within three years. Even after kidney transplantation, recurrence occurs in 20–60% of patients, severely impacting survival and quality of life. Until now, treatment has primarily involved conservative approaches such as RAS (renin–angiotensin system) inhibitors to control blood pressure, with dialysis or kidney transplantation considered only after significant renal function decline. This represents a major unmet need. The active ingredient in Nefecon, budesonide, is already marketed in Korea. Similar to antibody-drug conjugates (ADCs), which are targeted anticancer drugs designed to deliver cytotoxic anticancer agents used in chemotherapy to only the target site—cancer cells—thereby improving efficacy and safety, this is a targeted therapy designed to target Peyer's patches in the ileum, the final part of the small intestine. The initial stage of IgA nephropathy is the production of Gd-IgA1 (galactose-deficient IgA1). Since Gd-IgA1 is primarily produced in the Peyer's patches of the ileum, Nefecon targets this. In other words, it is designed to fundamentally treat the cause of IgA nephropathy by reducing the production of Gd-IgA1, the causative agent of the disease. This is also why regulatory agencies such as the US FDA, European EMA, China NMPA, and MFDS designated Nefecon for accelerated review and granted expedited approval. In a global Phase III clinical trial, 9 months of Nefecon treatment reduced kidney function loss by 50%, with similar effects observed after two years of follow-up. Data presented at ASN 2023 further projected that 9 months of Nefecon therapy could delay the need for dialysis by 12.8 years. Jin-hyang Jeong, Secretary-General of the Korea Organization for Rare Diseases, stated at a policy forum hosted on the 19th by lawmaker Ji-a Han of the People Power Party, “In Korea, IgA nephropathy patients are typically diagnosed at an average age of 34, in their prime working years. They face the lifelong risk of dialysis or kidney transplantation.” Jeong added, “Rather than spending the budget to maintain patients after renal function is lost, it is far more cost-effective to intervene earlier to prevent kidney damage. Special reimbursement coverage should be applied for severe IgA nephropathy patients.” Meanwhile, Nefecon received its first global approval from the U.S. FDA in December 2021 under the brand name Tarpeyo as the first and only approved treatment for IgA nephropathy. In Europe, it was conditionally approved in July 2022 under the brand name Kinpeygo and received full approval in July 2024. As of September 2025, Nefecon is reimbursed in the U.S., U.K., Italy, and China.
