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- 2026-05-16 16:40:43
- Opinion
- [Reporter’s View] Regrets in GOV's COVID-19 responses
- by Mar 30, 2022 06:09am
- “Gullmoosae” is a newly coined Korean word commonly used by stock investors to refer to investors who have lingering buy/sell regrets. The word is a combination of the Korean word ‘~halgul (should've)’ and the bird ‘engmossae (parrot),’ which describes the individual investor who regrets the past every time without buying or selling in advance. The government’s response to COVID-19 is not so different from these ‘Gullmoosae’ investors. Korea has already suffered two out-of-stock crises - the lack of COVID-19 self-diagnosis kits in January followed by the lack of respiratory disease treatments such as cold medicine and antipyretics in March – due to the surge in demand that arose due to the government’s policy change to ‘With-COVID-19’ earlier on this year. The government had urgently requested companies to expand their productions after the issues arose, but this was not the kind of problem that could be resolved in a matter of days. Just take the COVID-19 self-diagnostic kits as an example. The government had shown reluctance in using the tests until last year, citing the low reliability of the tests. As a result, the kits were approved, but rarely sold in the pharmacies and were considered a nuisance. This was why the companies had minimized the production of domestic products and increased exports. And then, the companies received this request for mass production from the government after a sudden policy change. The companies were barely able to meet the requested amount by changing the export products to domestic use and temporarily including value-pack products. However, most were taken by the government, and It was difficult to find kits on the market. Also, the front-line pharmacies experienced chaos due to the work of subdividing kits and fluctuating prices. Consumers also had to go from pharmacy to pharmacy and convenience stores to purchase the kits. The situation caused by the shortage of respiratory disease treatments is more severe. Not many companies specialize in treating respiratory diseases, and the companies had reduced their target manufacturing goal compared to the previous years. However, with the rapid surge in the number of COVID-19 cases, companies were suddenly hit with the sold-out bomb. It was only at this time around that the government hurriedly called on the pharmaceutical companies to and visited production plants to request supply expansions. However still, with large amounts of the urgently produced supplies taken by the government, customers are still having trouble finding the drug at pharmacies. The government’s complacent policy judgment was what caused this confusion throughout the industry. Due to the unplanned increased supply of cold medicines, pharmaceutical companies are unable to produce the other medicines. Eventually, the out-of-stock situation that was limited to cold medicines has spread to other unrelated medicines. And the pharmacists and pharmaceutical company employees were left to deal with the numerous inquiries that arose. The government had started considering transitioning to the With-COVID-19 around mid-last year. Although the period of the transition was adjusted due to various variables including the spread of the Omicron variant if the government had simulated the various situations that could arise when switching to the With-COVID-19 era, they could have stockpiled a sufficient amount in advance. It is not difficult to predict that the demand for self-diagnostic kits would increase if people who are not in the high-risk group are first tested with self-diagnostic kits, and the increase in patients with mild symptoms would increase the demand for cold medicines and antipyretics. In this sense, the journalist hopes that the government leaves no more regrets behind in the making of its measures for COVID-19.
- Company
- Dupixent shows marked effect in Korean severe asthma patient
- by Mar 30, 2022 06:09am
- Study analysis results on Sanofi’s allergic disease treatment ‘Dupixent (dupilumab)’ have shown that the drug has a superior effect on severe asthma patients in Korea. Based on the sub-analysis results, Sanofi is pursuing a reimbursement extension for Dupixent in asthma in Korea. At the webinar on the ‘Present state of severe asthma treatment in Korea’ that was held by Sanofi on the 29th, Professor You-Sook Cho, Division of Allergy and Clinical Immunology at Asan Medical Center, disclosed the first-ever Korean sub-analysis data from the global Phase III QUEST trial on Dupixent that was conducted on asthma patients. The QUEST trial compared the efficacy and safety of Dupixent and placebo in 1,902 patients with moderate-to-severe type 2 asthma. Its primary efficacy endpoint was were annualized rate of severe exacerbation events during the 52-week study period and changes from baseline in pre-bronchodilator FEV1 which is commonly used to test liver functions. Of the enrolled patients, 74 were Korean, and most were severe asthma patients who have experienced severe asthma exacerbation twice. 사노피 듀피젠트 온라인 미디어 세미나 캡처 The Korean subanalysis results showed that annualized severe exacerbation rates were significantly reduced with Dupixent compared to placebo (0.259 vs 1.942). Also, in patients with baseline blood eosinophil count of ≥150 cells/μL and baseline FeNO ≥ 25 ppb, the severe exacerbation rates fell 94% and 92%, respectively, compared to placebo with the use of Dupixent. Cho said, “I could feel the reduction in asthma exacerbations in the field while treating patients with Dupxient for the trial” In terms of Pre-bronchodilator FEV1, the Dupixent-treated group showed significant improvement from week 2, the effects of which lasted during the treatment period. At week 12, the Dupixent-treated group showed a mean improvement of 560mL, and a significant improvement of up to 380mL compared to placebo at week 52. Cho said, “We obtained very encouraging results that Dupixent can maintain lung function through the FEV1 test. Usually, patients feel an improvement from 120mL, and therefore the 560 mL improvement in the Dupixent group is very significant.” The incidence of treatment-related adverse events and serious adverse events in the Korean sub-analysis was comparable in the Dupixent group and the placebo group. Comparing the Korean sub-analysis results with the total clinical trial results, Dupixent showed a higher effect on Koreans. Cho said, “Korean asthma patients had shown less symptom control than in Western countries before Dupxient, I believe that’s why Koreans were able to get a greater effect using a good drug. Study results showed a very significant effect in Korean patients with severe asthma, and even compared to the results of the entire study, the severity of asthma exacerbation rate and FEV1 were more significantly improved in Korean patients.” Cho added, “Before the introduction of new biologics, we could only prescribe steroids to severe asthma patients. After using Dupixent for 3 years, not only did I experience a reduction in the use of steroids in my patients, but their lung function had also improved, with less symptom exacerbation. However, it is a shame that we cannot easily prescribe the drug due to limited reimbursement standards,” Currently, Dupixent is not reimbursed for severe asthma. Cho said, “I wish we could use this strong and effective weapon, Dupixent, in a more broad range of patients.” Sanofi said, “We have applied for the reimbursement expansion in March last year, and will make our best efforts to bring good news to our patients in Korea."
- Policy
- Multidrug-resistant ‘Zavicefta’ applies for approval
- by Lee, Hye-Kyung Mar 29, 2022 05:54am
- Pfizer Korea has applied for the approval of its important treatment for severe gram-negative bacterial infection, ‘Zavicefta.’ Zavicefta, which received marketing authorization in 2016. is a combination drug that contains the third-generation ceftazidime. According to industry officials on the 28th, Pfizer Korea recently submitted an application for the marketing authorization of Zavicefta to the Ministry of Food and Drug Safety. Zavicefta was developed to address the urgent need for new antibiotics in severe infections that cause serious problems such as multidrug-resistant pseudomonas aeruginosa or carbapenem-resistant gram-negative Enterobacteriaceae and extended-spectrum-lactamase (ESBL) producing intestinal bacteria. Zavicefta is used for the treatment of adult patients suffering from complicated intra-abdominal infections (cIAI); complicated urinary tract infections (cUTI), including pyelonephritis; hospital-acquired pneumonia (HAP); and the treatment of aerobic Gram-negative infections in adult patients who have limited treatment options. Zavicefta was developed by AstraZeneca. On August 24th, 2016, the company sold the global development and sales rights for its low molecular weight antibiotic business outside the United States to Pfizer.
- Policy
- Will the migraine tx Reyvow step on the same track
- by Lee, Tak-Sun Mar 29, 2022 05:54am
- IldongIldong Pharmaceutical's domestic copyrighted migraine drug Lasmiditan seems to be speeding up its benefit using the patent-approval linkage system. According to the industry on the 28th, the HIRA is recently listening to opinions on whether the migraine treatment Reyvow 50 & Reyvow100mg is eligible for medical care benefits through related conferences. Reyvow is known as the brand name of Lasmiditan, which Ildong Pharmaceutical secured domestic copyright in 2013. The group signed a development partnership and a domestic sales license agreement with CoLucid of the United States, the original developer of the drug. In 2017, CoLucid was acquired by global pharmaceutical company Eli Lilly also holds Lasmiditan's global rights. Reyvow was approved by the U.S. FDA in October 2019, and then Ildong started a bridging study for domestic permits. In January, the MFDS was found to have ended Reyvow's safety and effectiveness review. As a result, it is understood that the screening is underway using the patent-approval linkage system. It is a system that allows the MFDS to apply for a benefit decision before marketing approval based on this data when safety and validity screening are completed. Usually, it is applied after approval from the MFDS, but using the patent-approval linkage system can shorten the evaluation period by 30 to 60 days. Ildong plans to sell Reyvow domestically this year. Reyvow is the first migraine treatment to act on serotonin (5-HT) 1F receptors and has a mechanism to lower neuropeptide release and inhibit pain delivery pathways, including trigeminal nerves. It acts selectively on serotonin receptors and is characterized by no cardiovascular side effects due to vasoconstriction.
- Company
- Daewoong’s ‘Fexclu’ speeds up overseas market penetration
- by Kim, Jin-Gu Mar 29, 2022 05:54am
- Daewoong Pharmaceutical is working to target the global market with ‘Fexclu tab (fexuprazan),’ its new drug for P-CAB gastroesophageal reflux disease (GERD).’ The company had signed 6 export agreements with 15 countries in North America, Latin America, China, and the Middle East, which amounts to ₩1.2 trillion. In the case of the Southeast Asian market, the company plans to export directly through its own local subsidiary. On the 28th, Daewoong Pharmaceutical announced that it has applied for the marketing authorization of Fexclu through its local subsidiaries in the Philippines, Indonesia, and Thailand. As its local corporation in Southeast Asia is classified as a subsidiary of Daewoong Pharmaceutical, their sales are expected to be counted as Daewoong Pharmaceutical's exports. Daewoong Pharmaceutical expects its exports for Fexclu to amount to ₩520 billion in the 3 Southeast Asian countries and will be applying for its authorization in other Southeast Asian countries soon. Analysts believe Fexclu’s penetration into the global market will accelerate with its entrance into the Southeast Asian market. Since 2020, Daewoong Pharmaceutical has signed a series of contracts with North America, Latin America, China, and the Middle East to export its Fexclu technology or its finished drug. According to Daewoong Pharmaceutical, the company has 6 Fexclu export agreements in place, which amounts to ₩1.2 trillion. In January 2020, it signed a contract with the Mexican company Moksha8 for the technology exports of its finished exports worth $44.42 million (about ₩54 billion), followed by a series of contracts worth $72.58 million (about ₩89 billion) with Brazil's EMS in August. In March last year, it signed a $339.55 million (about ₩420 billion) contract with China's Shanghai Haini Pharmaceutical and a $430 million (about ₩530 billion) technology export contract with the U.S. and Canada's Neurogastrx in June. Separate from the technology export, Daewoong Pharmaceutical was able to secure a 13.5% stake in Neurogastrx. In the same month, Daewoong Pharmaceutical had signed a contract to transfer the local licenses and sales rights in four countries, Colombia, Ecuador, Peru, and Chile to 'Pharma Consulting Group (BIOPAS)’ in South America. Its figure amounts to $29.26 million (₩36 billion). In October, it then signed a contract with ‘Aghras Healthcare Limited’ in the Middle East to supply Fexclu to Saudi Arabia, the United Arab Emirates, Kuwait, Bahrain, Oman, and Qatar for the next 10 years. The 10-year sales volume as expected by the two companies is $82.97 million (about ₩100 billion). Through the exports agreement, the company expects it can earn up to ₩1.2 trillion with the agreements signed in 15 countries in North America, Latin America, China, and the Middle East. Seng-Ho Jeon, CEO of Daewoong Pharmaceutical, said, "We will submit an application for the marketing authorization of our product to another overseas country within this year. We will make efforts to accelerate Fexclu's entry into the global market in earnest." Fexclu is Daewoong Pharmaceutical’s new drug for P-CAB gastroesophageal reflux disease (GERD)’ that reversibly blocks the proton pump that secretes gastric acid from the stomach wall.
- Product
- Only Paxlovid's prescription continues instead of Lagevrio
- by Jung, Heung-Jun Mar 29, 2022 05:54am
- Lagevrio, a Merck coronavirus PO treatment, has been supplied to pharmacies since the 26th, but has not yet been prescribed. According to pharmacies on the 28th, no code has been registered in the billing program. Pharmacy A in Seoul said, "In the case of clinics, prescriptions will only be possible if they are prescribed by hand," adding, "There is no prescription of Lagevrio yet." Other pharmacies received 20 supplies, but there was no prescription over the weekend, so Lagevrio's inventory remained the same. Another pharmacy B in Seoul said, "Only Paxlovid was prescribed over the weekend, and there was no prescription of Lagevrio. It will be prescribed little by little this week." As Paxlovid is relatively effective and is supplied first, the follow-up treatment, Lagevrio, is expected to play a complementary role. Paxlovid should be used to be taken in patients with liver disease and kidney disease. Lagevrio has fewer restrictions on taking than Paxlovid, but pregnant women or children and adolescents under the age of 18 are excluded from the medication. Pharmacy C in Gyeonggi do is expected Lagevrio to be used complementarily only for patients who do not have or cannot use Paxlovid." In this regard, the government also stipulates that Paxlovid should be prescribed first, but patients with limited medication or difficulty using other treatments can be prescribed Lagevrio.
- Policy
- BMS acute myeloid leukemia tx Onureg was approved
- by Lee, Hye-Kyung Mar 29, 2022 05:54am
- Onureg 200mg and Onureg 300mg, the first PO drugs were approved. Currently, Azacitidine-based AML treatments, which are approved in Korea, are injections with Celgene's Vidaza100mg, Boryung Pharmaceutical's Vizadakin and Samyang Holdings' Azalid 100mg and Azalid 150mg, and Onureg has become the first oral treatment. The MFDS (Director Kim Kang-rip) recently approved BMS' AML treatment Onureg (Azacitidine). Onureg is an oral drug with a pink oval film coating and has the advantage of being administered regardless of meals. Indications can be used to achieve CR or CRi with incomplete hematological recovery after induction therapy, regardless of whether or not publicly announced therapy is performed, and to maintain therapy in adult patients with acute myeloid leukemia who are not suitable for HSCT. To administer Onureg, it must be initiated and monitored by a physician who has experience in chemotherapy, and should not be used interchangeably with injectable Azacitidine due to different exposure, dose, and administration schedules. Meanwhile, Onureg has been in the process of licensing items in Korea since the U.S. FDA approved in 2020.
- Company
- Wakix, a narcolepsy tx, can be prescribed at hospitals
- by Eo, Yun-Ho Mar 29, 2022 05:53am
- Wakix, a narcolepsy treatment, can be prescribed at general hospitals. According to related industries, Mitsubishi Tanabe Pharma's Wakix passed the Drug Committee of Seoul National University Hospital and other medical institutions. Wakix has been competing with Handok Teva's Nuvigil since last month as insurance benefits have been available. This drug is a new mechanism for increasing histamine concentration in the brain as a counteractive and antagonist that selectively binds to histamine H3 receptors. Nuvigil, an active isomer of sleep seizure treatment Provigil, is a drug that promotes awakening by activating dopamine in the brain and improves the duration of existing drugs. Hypnosis, a rare and intractable disease, has limited treatment options in Korea. In the United States and Europe, Modafinil, Sodium oxybate, Solriamfetol, and Pitolisant are used as narcolepsy treatments, but only Modafinil and isomeric Armodafinil are licensed in Korea. Narcolepsy is a sleep disorder disease characterized by confusion in the sleep awakening cycle and abnormal expression of REM sleep due to the loss of neurons that produce a neurotransmitter called Hypocretin in the brain. Symptoms include EDS (Excessive Daytime Sleepiness) and cataplexy, where REM sleep is expressed in awakening. Cataplexy is known to occur in 70% of narcolepsy patients. Wakix is the first drug approved in Korea to prove its clinical efficacy and safety. Wakix, a new drug developed by French pharmaceutical company Bioprojet Pharma, has been prescribed to narcolepsy patients in European countries such as the UK, France, and Germany since it was first approved as a rare drug by the EMA in March 2016. In August 2019, it was approved by the FDA.
- Company
- Expanding Entresto benefits/maximizing tx for inpatients
- by Mar 29, 2022 05:53am
- Entresto, Novartis' chronic heart failure treatment, has expanded both indications and benefits. Enresto can be used even in patients with more than 40% and less than 60% of the ejection fraction, which has been in great demand. In addition, it is expected that Entresto's position will be further strengthened as hospitalized heart failure patients can use Entresto as a primary drug. Novartis Korea held an online press conference on the 24th to commemorate the expansion of Entresto benefits and indications. Kang Seok-min, a professor of cardiology at Yonsei University's Sinchon Severance Hospital, and Cho Hyun-jae, a professor of circulatory medicine at Seoul National University Hospital, attended to share the meaning of expanding benefits. rom the left, Park Soo-jin, director of the Cardiovascular Metabolism Division of Novartis Korea, Kang Seok-min, professor of cardiology at Yonsei University Sinchon Severance Hospital, and Cho Hyun-jae, professor of circulatory medicine at Seoul National University Hospital Entresto is the first Angiotensin receptor-Neprilsysin inhibitor (ARNI) treatment in Korea and the only new drug that works directly on the heart. It acts on cardiac nerve hormones in two ways to activate NP nerve hormones that are beneficial to cardiovascular systems, while suppressing RAAS that is harmful to cardiovascular systems. In February, Entresto added an indication of 'reducing the risk of death from cardiovascular disease and hospitalization due to heart failure' in patients with chronic heart failure with lower left ventricular systolic function than normal. Starting this month, for patients who have been hemodynamically stabilized after hospitalization due to acute non-compensatory heart failure, salaries have also been expanded to those without ACE inhibitors or angiotensin II receptor blocking. Entresto can be reimbursed as a primary drug for inpatients. According to Professor Kang Seok-min, 83% of patients with chronic heart failure are hospitalized more than once for acute heart failure, and one in four patients is hospitalized again for 30 days after discharge. Up to 10% die. Effective initial treatment that can reduce re-hospitalization is important. Entresto is recommended as a standard treatment in domestic and foreign heart failure treatment guidelines, but it was difficult to use it initially in Korea as a limited standard. Professor Kang said, "Inpatients have not been able to use Entresto in the first round, but clinical studies have supported the importance of using drugs that can reduce mortality at the time of hospitalization," adding, "Now domestic inpatients are expected to use Entresto to significantly reduce re-entry and mortality." Entresto has also expanded its use in patients with a heart rate of more than 40% to less than normal (about 60%), which has been in unmet demand. Reduced hardness of ejection rate and some conservative patients can be treated with Entresto. Throughout this, Entresto has become the drug with the widest range of chronic heart failure indications in Korea. Entresto showed the greatest clinical effect in patients with a heart rate of 60% or less. Professor Cho Hyun-jae said, "When looking at the left ventricular ejection rate according to the quintile, it showed a consistent positive effect from less than 25% to less than 60%," adding, "9.6% of patients who preserved the ejection rate were progressing heart failure a year later. There have been many studies so far, but Entresto is expected to benefit from proving its effectiveness for the first time." Professor Cho then said, "Recently, SGLT-2 inhibitors have also shown some effects in preserving the ejection rate," adding, "Entresto and SGLT-2 inhibitors play different roles in three axes of heart failure treatment. Therefore, since the two drugs are not in a substitute relationship, but in a complementary relationship, standard treatment will move toward using Entresto and SGLT-2 together in the future, he added. Entresto surpassed 30 billion won in outpatient prescriptions within five years of its launch. Last year, prescriptions amounted to 32.3 billion won, up 37.3% from the previous year.
- Policy
- Will the separation of the Ministry of Health be promoted?
- by Lee, Jeong-Hwan Mar 28, 2022 06:10am
- Yoon Seok-yeol's presidential transition committee seems to be discussing the necessity of separating the Ministry of Health and integrating and absorbing the MFDS in the process of discussing the reorganization of the government after the inauguration of the next government. As the pandemic era became commonplace due to COVID-19, the role of the health sector grew, and the medical community strongly urged the independence of the Ministry of Health and even academia insisted on the necessity of the Ministry of Health. According to Yoon Seok-yeol's transition committee and related academia on the 27th, various discussions are taking place over the next government organization, including the reorganization of the MOHW. Yoon's transition committee receives reports from each government department until the 29th, while keeping in mind the need for independence of the Ministry of Health along with the abolition of the Ministry of Gender Equality and Family. Some say that if the Ministry of Health becomes independent, the MFDS will also inevitably change its organization. With the independence of the Ministry of Health, there is a possibility that the MFDS will be integrated and absorbed as it was an organization under the MOHW in the past. If the Ministry of Health becomes independent from the MOHW, the number of personnel is about 400, and the MFDS should be integrated to strengthen and exist the ministry functions. In addition, the Ministry of Health may divide areas other than the food sector within the MFDS after independence from the Ministry of Health as there is a need to transfer food sector work within the MFDS. The medical community strongly agrees with the independence of the Ministry of Health. The Ministry of Health should be separated to respond to the public health crisis caused by the outbreak of infectious diseases and foster the health care sector. The KMA proposed several government reorganization plans to establish the Ministry of Health and manage the KDCA, the MFDS, and public health centers since Yoon was a presidential candidate. Independence of the Ministry of Health is also emphasizing the necessity of related academia. Kim Eun-joo, a professor of social science at Hansung University, appealed the need for independence from the Ministry of Health at a seminar hosted by the KAOS and the KAPAR21 on the 25th. Professor Kim Eun-joo said, "The MOHW should separate health functions and deploy the KDCA as a member of the Ministry of Health to strengthen the health and safety system based on expertise in the health sector." She said, "We need to establish an effective response system to infectious diseases such as COVID-19. The MFDS should also strengthen its health risk factor management function," she argued. Professor Kim argues that the MOHW should be divided into the Ministry of Health and that KDCA, the ministry in charge of quarantine, should be assigned as a member of the Ministry of Health. Kim Yoon-kwon, a senior researcher at KIPA, also mentioned the establishment of the new Ministry of Health, saying, "We need to redesign welfare and health functions to secure function completeness based on our expertise." The transition committee plans to collect expert opinions on independence of the Ministry of Health, reorganization of the KDCA, and integration of the MFDS. The plan to reorganize the government is expected to be outlined only after the transition committee's business report is completed and before the next government is launched.
