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- 2026-05-03 23:15:15
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- MS drug development poses a big challenge for pharma
- by Son, Hyung-Min Sep 10, 2024 05:48am
- Pharmaceutical companies based in South Korea and overseas are having difficulties developing new drugs for multiple sclerosis. Sanofi failed to demonstrate the drug's efficacy in some parts of clinical trials, and Merck's Phase 3 clinical trial did not meet primary endpoints. However, Sanofi announced that it will attempt to receive approval from the U.S. Food and Drug Administration (FDA) since the company acquired results confirming the efficacy in some parts of the clinical trial. In South Korea, D&D Pharmatech and AprilBIO jump into drug development. Sanofi fails to meet the primary endpoints in some of the Phase 3 clinical trials According to industry sources on September 7th, Sanofi recently completed clinical trials for 'tolebrutinib,' a new drug candidate for multiple sclerosis, and announced that the company will still plan to file for FDA approval. Tolebrutinib is an oral Bruton tyrosine kinase (BTK) inhibitor that works by selectively inhibiting immune responses in multiple sclerosis by regulating B lymphocytes and disease-related microglia. Sanofi acquired the U.S.-based biotechnology company Principia Biopharma for US$3.7 billion (about KRW 4.95 trillion) in 2021 and secured the development rights for Tolebrutinib. Multiple sclerosis is a chronic disease in which the myelin sheaths are damaged due to autoimmune inflammatory responses. Damages to the myelin sheaths cause muscle weakening, fatigue, and vision impairment, and the disease could lead to atraumatic disorders. As of 2022, there are approximately 2674 patients with multiple sclerosis in South Korea, and people aged 20-40 account for 62% of all patients. Until now, antibody medications such as Tysabri (natalizumab), Gilenya (fingolimod), and Mabthera (rituximab) have been used for treating multiple sclerosis. However, there are ongoing requests for new drugs. Sanofi confirmed the efficacy of tolebrutinib through the Phase 3 'HERCULES' study, which involved patients with nonrelapsing secondary progressive multiple sclerosis (nrSPMS). The results showed that tolebrutinib shortened the time to reach confirmed disability progression (CDP), which has been used as the primary endpoint, compared to the placebo group. However, GEMINI 1 and 2 of the Phase 3 trials, which involved patients with relapsing multiple sclerosis, failed to demonstrate the efficacy of tolebrutinib. In these clinical trials, tolebrutinib failed to reduce the annualized relapse rate (ARR) compared to Aubagio (teriflunomide). Notably, tolebrutinib delayed the time till relapse when the secondary primary endpoints were analyzed. Although GEMINI clinical trial results did not meet the primary endpoint, Sanofi plans to file for FDA approval since it secured positive results from the HERCULES study. In South Korea, D&D Pharmatech and AprilBio jump into the field D&D Pharmatech recently received the Investigational New Drug (IND) approval for the Phase 2 clinical trials of its 'NLY01,' a new drug candidate for multiple sclerosis. NLY01 is a GLP-1 (glucagon-like peptide 1) receptor agonist that works by inhibiting neuroinflammation, which is known as the major cause of degenerative brain diseases and protecting neurons. The NLY01 Phase 2 trial results for Parkinson's Disease were disclosed in 2020. However, 36 weeks of NLY01 administration, which was set as the primary endpoint, did not show statistically significant improvement in symptom alleviation compared to the placebo group. In detail, at 24 weeks of administration, a significant difference was found between the NLY01 treatment group and the placebo group. However, between 24 and 36 weeks, the placebo group’s symptoms showed more improvements than those of the NLY01 group. Then, D&D Pharmatech changed the clinical plan of NLY01 as a new drug for multiple sclerosis. As NLY01 showed effects in regulating neuroinflammation in patients aged 60 years and below in the Parkinson's Disease clinical trial, D&D Pharmatech plans to investigate the candidate's potential as a new drug for multiple sclerosis. The ongoing Phase 2 clinical trial evaluates whether NLY01 reduces neurodegeneration-related imaging indexes in patients with multiple sclerosis. The primary endpoints include changes to the normalization of cerebral volumes. AprilBio has expanded the clinical indication of 'APB-A1,' a new drug candidate for immune disease, to multiple sclerosis. During a conference call, AprilBio's U.S.-based partnering company, Lundbeck, announced that it would expand the APB-A1 development plan to include multiple sclerosis in addition to thyroid eye disease (TED). In 2021, AprilBio out-licensed APB-A1 to Danish pharmaceutical company Lundbeck for US$448 million (approximately KRW 540 billion). APB-A1 is a new drug candidate that inhibits CD40L. CD40L is commonly found in activated T cells following inflammation. Large quantities of cytokines are released when T Cells’ CD40L binds to CD40 of natural killer cells. APB-A1 works by targeting CD40, inhibiting the formation of cytokine-releasing antibodies through B cells and natural killer cells. Now, UCB’s dapirolizumab and the U.S. biotech company Horizon Therapeutics’ Dazodalibep are under development with mechanisms of action similar to APB-A1.
- Company
- CAR-T cell therapy Yescarta expected to enter the KOR market
- by Eo, Yun-Ho Sep 10, 2024 05:48am
- Product photo of Gilead Sciences Another new CAR-T cell therapy 'Yescarta' is anticipated to enter the Korean market. The Ministry of Food and Drug Safety (MFDS) recently posted that it has designated an orphan drug for Gilead Sciences' Yescarta (axicabtagene ciloleucel). The designated indication will include ▲Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or primary mediastinal B-cell lymphoma (PMBCL) who have undergone two or more systemic treatments ▲Adult patients with DLBCL who have relapsed or refractory within 12 months after the first-line chemoimmunotherapy. Yescartav is a CAR-T cell therapy that received the first approval from the U.S. Food and Drug Administration (FDA) as the third-line treatment in October 2017. After receiving approval from the European Commission (EC), the drug has expanded to the second-line treatment. In 2021, it became available for use in treating follicular lymphoma. The efficacy of Yescarta as the third-line treatment has been confirmed through the ZUM-1 clinical study. The study reported a 5-year survival rate, showing that 42.6% of all patients treated with Yescarta survived for five years, and 92% of those no longer needed additional cancer treatment. Then, the ZUMA-7 Phase 3 clinical trial confirmed the drug's efficacy for the second-line treatment. It was the first-in-class for a CART-T cell therapy, the largest in scale, and the longest follow-up trial. 359 patients world-wide were randomly assigned to receive one-time treatment of Yescarta or the existing standard-care second-line therapy. The analysis results presented at the American Society of Clinical Oncology conference (ASCO 2023) last year included a median follow-up at 47.2 months, at which the median value of overall survival (OS) with Yescarta was not reached. However, Yescarta's death rate was 27%, which was statistically lower than the control group's 31.1 months. The OS at 48 months was 54.6% for Yescarta and 46.0% for the control group. Yescarta treatment showed consistent survival benefits in pre-assigned subgroups, including age groups, refractory at the first-line therapy, early relapse, or high-grade B-cell lymphoma (HGBL). Additionally, excluding the impact of treatment shift using the pre-assigned method, Yescarta's risk of death was 39% lower than the control group. In South Korea, Novartis Korea's 'Kymriah (tisagenlecleucel)' was the first CAR-T cell therapy to receive approval. In March, Janssen Korea's 'Carvykti (ciltacabtagene autoleucel)' was approved. Kymriah is now listed for insurance reimbursement, and Carvykti is still a non-reimbursed drug.
- Company
- Is the heyday of domestic flu vaccines coming to an end?
- by Moon, sung-ho Sep 10, 2024 05:48am
- Competition among pharmaceutical and biotech companies with influenza (flu) vaccines is intensifying more than ever. As more and more companies, including global pharmaceutical companies, are seeking to supply vaccines on-site, and specialized vaccines are being launched for each age group, the competition is expected to be unprecedented this autumn. # In particular, the formation of a non-reimbursed market for both vaccines has become a hot topic in the field, especially in the context of the resurgence of COVID-19. However, industry insiders do not expect large-scale co-vaccination to be carried out among adults, except for high-risk patients who are eligible for the National Immunization Program (NIP). According to industry sources on the 7th, the vaccine contracted by the Korea Disease Control and Prevention Agency (KDCA) for the ‘2024-2025 Influenza NIP Project’ is 11.7 million doses worth KRW 12.9 billion. This is more than the previous year's contracted volume of 11.21 million doses. KDCA signed contracts with GC Biopharma, Sanofi, Boryung Biopharma, SK Bioscience, Korea Vaccine, and Il-Yang Pharmaceutical. This is similar to last year. However, the details are different. Last year, GC Biopharma supplied less than planned after making the highest bid through the NIP, but the company made a different choice this time. Last year, GC Biopharma bid to supply 4.3 million doses, but only 1.74 million doses were delivered through NIP due to its supply price being pushed back. In other words, the doses that the company was unable to supply through the NIP were released into the non-reimbursed adult vaccine market. But the situation was different this year. GC BIopharma bid the highest price for the NIP, at KRW 10,810 per vaccine, and the largest volume of 2.65 million doses. The company was followed by SK Bioscience, which bid KRW 10,470 per vaccine for 2.55 million doses. It is also worth noting that Sanofi, which bid the lowest price at KRW 10,340, will supply 2.15 million doses. In addition, Il-Yang Pharmaceutical and Korea Vaccine will supply 2 million doses and Boryung Biopharma will supply 1.25 million doses to NIP. In addition, GSK will supply the flu vaccine Fluarix Tetra for the pediatric NIP. As a result, most of the flu vaccines are included in the NIP. The difference this year is in the adult vaccine market for the elderly. This is because Sanofi is planning to launch ‘Efluelda,’ a high-dose influenza vaccine for people aged 65 and over in time for this year's flu season in addition to the existing Vaxigrip. It is worth noting that CSL Seqirus launched ‘Fluad Quad’ last year for the 65+ age group. Fluad Quad was the first vaccine to enter this market, but the subsequent entry of Efluelda has created competition in the non-reimbursement vaccine market for the 65+ age group. While the NIP includes people aged 65 and older, clinical sites say there is a clear market for non-reimbursed Fluad Quad given the vaccination experience last year. “Given the situation last year, 1 in 10 of the elderly sought the vaccine,” said an otolaryngologist who requested anonymity. “I brought in about 100 units, which I used with the 1,200 doses of the NIP vaccine. I think the point that it is particularly effective for those aged 65 and older has made them aware of the need.” “Last year, the price of the vaccine was KRW 40,000 to 50,000, but this year, we need to consider the entry of its competitor,” he said. “There may be differences by region, but the price of the general vaccine is likely to be between KRW 25,000 and 30,000, and the price of the vaccine for the elderly is likely to set KRW 10,000 higher.’ Another point of interest is how the reemergence of COVID-19 will affect the flu vaccination season later this year. According to KDCA, 837 hospitalized patients were reported in the COVID-19 sentinel surveillance report at Week 35, a 28.0% decrease from Week 34 (1,163). This is a 48.2% decrease compared to Week 33 (1,464), 2 weeks earlier. The pathogen detection rate has also been decreasing for 2 consecutive weeks, from Week 33 (43.4%) to Week 34 (39.0%) to Week 35 (34.0%). COVID-19 viral concentrations in the wastewater surveillance also decreased by 27% from 2 weeks ago. While it is believed that the peak of the pandemic has passed, the government plans to continue to support COVID-19 vaccinations for high-risk groups, including those aged 65 and older and those who are immunocompromised. The clinical field is interested in the volume of non-reimbursed COVID-19 vaccinations alongside the flu vaccinations. If interest continues to rise, the patients may inquire about COVID-19 vaccinations during the flu vaccination season. In this situation, Moderna Korea, a leading vaccine supplier, has ended its relationship with Kwangdong Pharmaceutical and entered into a strategic partnership with Boryung Biopharma for the supply of COVID-19 vaccines in Korea. Through the partnership, Boryung Biopharma will provide medical information on Moderna's updated COVID-19 vaccine, which will be used in the government's ‘2024-2025 Season Inoculation Program,’ to healthcare providers in Korea. However, it is unlikely that many adults will be vaccinated with the non-reimbursed COVID-19 vaccine as it is relatively expensive. Currently, there is a consensus that the vaccine price will be in the mid-KRW 100,000 range without reimbursement. “The government seems to want to support COVID-19 vaccines to high-risk groups such as the elderly over the age of 65. Some of the other COVID-19 vaccines are currently in supply and their purchase price is in the KRW 100,000 range,” said Kyung-Geun Kwak, Chair of Seoul Physician’s Association (Seoul Medical Clinic) ”Because of this, the price of the COVID-19 vaccination will be in the mid- KRW 100,000 range. The flu had spread in Korea from August to September along with COVID-19, so those who had suffered inconvenience due to the 2 may likely seek vaccination for either disease.” Kwak added, “I understand that there are global policies in place, but personally I believe the COVID-19 vaccine is too expensive. “I doubt that relatively younger patients, except for high-risk groups, would be willing to receive vaccination at the price.”
- Company
- Livtencity's introduction raises expectations in the field
- by Hwang, Byung-woo Sep 10, 2024 05:47am
- The introduction of Livtencity (maribavir), a drug that can be prescribed to manage infections in transplant patients following the use of existing treatments, has been met with positive reviews in the field due to a lack of treatment options. Although the actual number of patients who will be prescribed the drug is limited, the drug is expected to play a role in the management of infections in patients who value their transplant opportunity. Sung-Han Kim, Department of Infectious Diseases, Seoul Asan Medical Center Sung-Han Kim, Professor of Infectious Diseases at Seoul Asan Medical Center, attended a media session organized by Takeda Pharmaceuticals Korea to discuss the paradigm shift in the treatment of patients with cytomegalovirus (CMV) infection. CMV is a double-stranded DNA virus that is a member of the herpesvirus family and is mainly transmitted through body fluids, white blood cells, and tissues such as transplanted organs. In Korea, about 94% of adults are known to be seropositive for CMV. For this reason, allogeneic hematopoietic stem cell transplantation or solid organ transplantation patients, whose immune function is temporarily reduced to control the body's rejection during the transplantation process, may develop latent CMV, rendering it an essential condition to manage. In Korea, up to 88% of patients after allogeneic stem cell transplantation and up to 55% of patients after solid organ transplantation experience CMV infection. CMV infection may be initially asymptomatic, but if not successfully treated, it can progress to CMV disease. CMV infection is also considered a major threat that increases the risk of graft rejection, opportunistic infections, and death. “People can be infected with CMV during adolescence to about 25 years of age and remain latent,” said Professor Kim, “and it can cause a number of diseases when the immune system is suppressed following transplantation. CMV infection in transplant patients is an indication of a poorer immune status, so it needs to be managed appropriately.” Currently, CMV treatment is divided into three phases: prophylaxis for those who do not have the virus, preemptive therapy for those who do have the virus but have not developed a disease, and treatment for those who have advanced to a disease. For solid organ transplant and allogeneic stem cell transplant patients, who are at high risk for CMV, ganciclovir (intravenous) and valganciclovir (oral) are used as first-line treatments. In the case of patients who show resistance or are refractory to antivirals and require second-line treatment, solid organ transplant patients are treated with ganciclovir or valganciclovir in combination with an adjusted dose of immunosuppressive agents. Foscarnet and cidofovir may also be considered, but their use is limited due to their non-reimbursed status. ”Livtencity is expected to serve as a promising new weapon for treatment of CMV...changing the guideline protocols remains a challenge” Livtencity has emerged in this situation. The drug was launched last year and has been granted reimbursement as a second-line treatment since April. Although the number of transplant patients is limited in Korea, the significance of its arrival is that it brings additional options to the field. Although several drugs are already used for CMV, there are patients who are refractory to the existing options, so Livtencity is expected to play a role as a later-line option. Kim said, “Organ transplants and bone marrow transplants are expensive, and there are cases where CMV can ruin the transplant. In an area where options are limited, Livtencity’s introduction is significant because it has a better effect and fewer side effects.” ‘As Livtencity is an oral pill, it can be taken as an outpatient treatment, which makes it more convenient for the patients,” added Kim. However, Kim believes that guidelines for post-transplant infection control need to be contemplated. While the growing options have improved patient access, it also comes with the risk of cuts. For allogeneic hematopoietic stem cell transplantation, the current treatment sequence is to use conventional first-line treatments such as ganciclovir and valganciclovir followed by Livtencity as a second-line treatment. MSD's Prevymis (letermovir) has also emerged as a prophylaxis for CMV infection, but it can only be used for up to 100 days after transplantation. “Prophylaxis after allogeneic stem cell transplantation is done most of the time, but due to the high cost of the drug and concerns about reimbursement cuts, the treatment is sometimes terminated at the wrong time or the right dose not used,” said Kim. “There is also a need for the hematology and infectious disease departments to discuss the treatment protocols to manage CMV after allogeneic stem cell transplantation.” “Various discussions need to be made to address these protocol issues, which is not easy in the current environment. We would need to sort out these protocols after the overall healthcare situation improves in Korea.”
- Company
- Eliquis generics to enter and reshape DOAC mkt in SEP
- by Moon, Sung-ho Sep 10, 2024 05:47am
- From this month (September), numerous generic drugs will be released in the direct-acting oral anticoagulant (DOAC) market. Following Bayer's Xarelto (rivaroxaban), Pfizer and BMS's Eliquis (apixaban) is also facing its patent expiry. According to industry sources on the 26th, the Ministry of Health and Welfare recently prepared a notice on the reimbursement listing of 18 pharmaceutical companies' products containing apixaban and began collecting opinions. When looking at the DOACs that are prescribed in internal medicine hospitals and clinics, Bayer’s Xarelto (rivaroxaban), followed by Boehringer Ingelheim’s Pradaxa (dabigatran), Pfizer and BMS’s Eliquis (apixaban), and Daiichi Sankyo’s Lixiana (edoxaban) are currently the major players in Korea’s market. Among these, Xarelto’s patent expired in the second half of 2022, and its decline in the prescription market has become more pronounced recently as domestic drugmakers have launched a slew of Xarelto generics. According to the drug research institution UBIST, Xarelto’s prescriptions plummeted 37% from KRW 49.4 billion in 2022 to KRW 31 billion in 2023. The downward trend has continued in the first half of this year, with sales around KRW 15.3 billion. Moreover, as another blockbuster, Eliquis, is scheduled to expire on September 10, the MOHW has announced that 18 Eliquis generics from pharmaceutical companies will be listed for health insurance reimbursement benefits. For reference, Eliquis continues to dominate the clinical scene with prescriptions worth KRW 77.3 billion last year. In the first half of this year, it recorded KRW 38.8 billion, but this sales flow is expected to change after the launch of generics. Upon the entry of generics, Daiichi Sankyo's Lixiana, which has recently been strengthening its market dominance, is expected to take the sole lead in the field. Lixiana, which is copromoted and sold by Daiichi Sankyo and Daewoong Pharmaceutical, recently surpassed Eliquis’s sales and rose to monopoly. Last year, Lixiana's domestic sales reached KRW 105.3 billion, and in the first half of this year, it recorded KRW 55.8 billion, maintaining an upward trend. A professor of cardiology at A University Hospital said, “Nothing would notably change in the field aDOACs are well used in clinical practice. If generics are released, prescriptions will naturally be dispersed between them as they may differ in terms of drug price.” A director of a frontline internal medicine clinic also said, “Following Xarelto, the patent expiry of major original drugs in the DOAC market has followed. I think Eliquis’s market will show a similar result to Xarelto’s. We have already been approached by sales representatives from various pharmaceutical companies requesting prescriptions from September following the launch of their respective generics.” “I can feel the pressure put on the sales representatives by pharmaceutical companies that have launched generics. Everybody rep had been asking us to just prescribe one case,” added the director.
- Company
- Hugel hosts Train-The-Trainer seminar for global medical aes
- by Kwon Sung-Yong Sep 09, 2024 09:45am
- Hugel Inc., a leading global medical aesthetics company, said on Monday it hosted the Train-The-Trainer program at the end of August with medical experts from overseas to improve their knowledge and practices of skin rejuvenation. Some 20 medical practitioners from nine countries, including the US, Australia, Canada, China, Taiwan, Japan, Indonesia, Kazakhstan and Colombia, attended the two-day seminar in Seoul with lectures and cadaveric demonstrations. The company hosted a cadaveric workshop at the Catholic Institute for Applied Anatomy of the Catholic University of Korea on the first day. The injection of botulinum toxin and hyaluronic acid fillers, which helps facial rejuvenation and a youthful gaze, and theory courses were led by Dr. Kyuho Yi, the director at Maylin Clinic Apgujeong, Soo-Bin Kim, professor at the Department of Anatomy of Yonsei University College of Dentistry and Hyun Jin Park, professor at Department of Anatomy of Daegu Catholic University School of Medicine. On the second day, the seminar was focused on advanced aesthetic injection techniques. Lectures and live demonstrations for skin rejuvenation were performed by Dr. Ho Sung Choi, the medical director of Piena Aesthetic Clinic, and Dr. Jong Jin Lee, the medical director of DayBeau Clinic. “The trainees were highly satisfied with the seminar which facilitated sharing injection techniques of Korean medical experts, by using Hugel products, deep knowledge and emerging trends in the medical aesthetics field via a well-structured curriculum. The training course helps experts from different markets grow as global medical aesthetic industry leaders. Hugel will continue to actively organize academic events in each market to improve medical practices for skin rejuvenation,” a Hugel official said. Hugel hosted Train-The-Trainer for the second time after the first one held in April in Seoul. The course in August was part of Hugel Expert Leader’s Forum (H.E.L.F.), the global academic forum for medical aesthetic professionals that the company has held every year since 2013. About Hugel Established in 2001, Hugel is a leading global medical aesthetics company that manufactures injectables for skin rejuvenation such as botulinum toxin, hyaluronic acid fillers and skin boosters as well as tissue-lifting threads and cosmetics products. The company is the only South Korean supplier to the world’s three largest botulinum toxin markets, the US, China and Europe. It exports medical aesthetic products to around 70 countries and operates eight global subsidiaries in the US, Australia, Canada, Taiwan, China, Hong Kong and Singapore.
- Company
- 'Vabysmo' likely to receive approval for third indication
- by Eo, Yun-Ho Sep 09, 2024 05:49am
- Product photo of Roche Korea 'Vabysmo,' the first bispecific antibody for the treatment of ophthalmologic disease, is under review for expanded indication for retinal vein occlusion (RVO) in South Korea. According to industry sources, Roche Korea has applied for expanded approval of Vabysmo (faricimab) from the Ministry of Food and Drug Safety (MFDS). The drug received approval for the RVO indication from the U.S. Food and Drug Administration (FDA) last October. Vabysmo is a treatment for macular degeneration that draws attention for significantly extending the administration interval compared to 'Eylea (aflibercept),' which has been the standard therapy. In South Korea, Vabysmo's prescription became available after it was approved for reimbursement listing for neovascular age-related macular degeneration (nAMD) and diabetes-related macular edema (DME) in October last year. Existing macular degeneration drugs used in South Korea are vascular endothelial growth factor-A (VEGF-A) drugs such as Novartis' 'Lucentis (ranibizumab),' 'Beovu (brolucizumab),' and Eylea. Unlike existing VEGF drugs, like Lucentis and Eylea, Vabysmo can also block the angiopoietin-2 (Ang-2) pathway, thus inhibiting new blood vessel formation. The analysis suggests that blocking two independent pathways can more effectively stabilize blood vessels and reduce inflammation, abnormal vessel growth, and fluid leakage than the VEGF-A pathway alone. RVO is Vabysmo's third indication. Its efficacy has been confirmed through the Phase 3 BALATON and COMOINO studies. In these clinical trials, Vabysmo achieved non-inferiority in the patient's vision improvement compared to Eylea. When treated with Eylea, the patients had continual vision improvements from the early stage. The safety profile of the trials was similar to previous study reports. According to the market research firm IQVIA, the domestic market for macular degeneration treatment generates KRW 110 billion in sales as of 2021. Eylea accounts for KRW 70.5 billion, and Lucentis accounts for KRW 35.1 billion of the total sales. The future impact of Vabysmo, which is expanding into various fields, on the market is to watch.
- Policy
- MFDS announces EUA application of new COVID-19 vaccine
- by Lee, Hye-Kyung Sep 09, 2024 05:49am
- An emergency use authorization process is in progress for new COVID-19 vaccines so that the disease control authorities can inoculate using the vaccines in October. On the 6th, the Ministry of Food and Drug Safety announced an application for emergency use approval of the ‘JN.1 variant-response recombinant protein vaccine for the prevention of COVID-19 caused by SARS-CoV-2 virus’. The EUA system allows vaccines requested by the Commissioner of the Korea Disease Control and Prevention Agency to be manufactured and sold for a limited time if there is no approved product in Korea. With the frequent reemergence of infectious diseases that threaten mankind, such as the swine flu and COVID-19, the U.S. Food and Drug Administration (FDA) established the Emergency Use Authorization (EUA) system to exempt the authorization process of medical devices that are in urgent need due to infectious disease pandemics. In Korea, the EUA was first introduced in 2016 for MERS, and during the COVID-19 outbreak, many vaccines and treatments were actively approved using the EUA system. The EUA application notification this time is for 320,000 doses of a new COVID-19 vaccine, which is believed to be Novavax's JN.1 COVID-19 vaccine, which the KDCA signed an agreement for in July. The KCDA said it has secured 5.23 million doses of Pfizer’s vaccine, 2 million doses of Moderna, and 320,000 doses of Novavax’s vaccine, as new COVID-19 vaccines to be used in the 2024-2025 season starting in October. Two of the vaccines that the KDCA procured the most – Pfizer's Comirnaty JN.1 COVID-19 Inj (bretovameran) (Sars-coronavirus-2 mRNA vaccine) and Comirnaty JN.1 Inj (single-dose vial) - have already been granted marketing authorization in Korea. Pfizer had first applied for marketing authorization of ‘Comirnaty Bivalent Inj,’ which is used for the existing pandemic variant, to expedite the approval of the new vaccine, by leaving a GMP review history in place. To receive formal approval for their COVID-19 vaccines, the companies need to submit data on non-clinical trials, clinical trials, quality and risk management plans, and manufacturing and quality control for marketing authorization and review. On the other hand, for EUA, the following requirements need to be satisfied: ▲ the applicant needs to be a drug manufacturer or importer; ▲ demonstrate that the drug is effective against the JN.1 variant of COVID-19 caused by the SARS-CoV2 virus; ▲ demonstrate that the safety and quality of the drug is ensured; ▲ and, in the case of imported products, the products need to have received measures equivalent to approval in a foreign country that conducts drug safety control at a level equal to or higher than that of Korea. During the last COVID-19 outbreak, the EUA system was used to shorten the document preparation period from 30 days to 7 days, the protocol approval and clinical trial period from 90 days to 22 days, and the final review and approval period from 80 days to 30 days.
- Company
- Jassen’s Balversa can be prescribed in general hospitals
- by Eo, Yun-Ho Sep 09, 2024 05:49am
- The new bladder cancer drug Balversa may now be prescribed in general hospitals in Korea. According to industry sources, Janssen Korea’s FGFR-inhibiting urothelial carcinoma (bladder cancer) drug Balversa (erdafitinib) has recently passed the drug committees (DCs) of tertiary hospitals including Seoul St. Mary's Hospital, Seoul Asan Medical Center, and Sinchon Severance Hospital, as well as the drug committees of medical institutions such as Hallym University Kangnam Sacred Heart Hospital, National Cancer Center, and Cheonam National University Hwasun Hospital. Balversa was approved by the Ministry of Food and Drug Safety in January 2022. However, it is still not reimbursed in Korea. Specifically, the drug is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with FGFR2 or FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy, which includes platinum-based chemotherapy, or whose disease has progressed within 12 months of neoadjuvant or adjuvant treatment with platinum-based chemotherapy. However, the approval of PD-1 and PD-L1-directed immuno-oncology agents in the first- and second-line settings that followed Balversa’s approval led to the need for Balversa to demonstrate efficacy in patients who previously received these agents. And the situation was addressed with the publication of Balversa’s Phase III THOR trial study, which demonstrated a prolonged overall survival (OS) benefit with Balversa over chemotherapy in patients with metastatic urothelial carcinoma with FGFR3/2 gene alterations whose disease progressed after first-line treatment with immuno-oncology agents. In the study, Balversa prolonged overall survival (OS) compared with chemotherapy in patients with metastatic urothelial carcinoma. Results showed that over a median follow-up of 15.9 months, the mOS was 12.1 months in the Balversa arm, reducing the risk of death by 36% compared with the 7.8 months in the chemotherapy arm. Based on these findings, the U.S. Food and Drug Administration granted Balversa formal approval in January, but with a more restricted indication than originally approved. The European Medicines Agency's Committee for Medicinal Products for Human Use recently recommended expanded indications for Balversa. Janssen Korea has also additional submitted results from the THOR study to Korea’s Ministry of Food and Drug Safety. Therefore, the company well may launch Balversa in earnest in the second half of the year in Korea. It remains to be seen whether Balversa will be able to go beyond landing in medical institutions and gain insurance coverage in Korea. Meanwhile, bladder cancer is one major cancer that has lacked a targeted therapy option. Balversa is the first targeted anti-cancer drug for bladder cancer with a novel mechanism of action that inhibits fibroblast growth factor receptor (FGFR). FGFR is a biomarker involved in cancer cell growth that is associated with various cancers. FGFR mutations are particularly common in bladder cancer, with 20 to 30% of patients carrying mutations.
- Company
- Vonjo receives orphan drug designation in Korea
- by Eo, Yun-Ho Sep 06, 2024 05:48am
- The oral myelofibrosis drug Vonjo has been designated as an orphan drug in Korea. The Ministry of Food and Drug Safety announced so on the 3rd through an orphan drug designation. Specifically, the drug is indicated for ‘adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF) with a platelet count
