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- 2026-04-12 18:23:58
- Policy
- Roche RET target anticancer drug Gavreto, approved in Korea
- by Lee, Hye-Kyung Mar 31, 2022 04:23pm
- Roche's non-small cell lung cancer treatment Gavreto (Pralsetinib)"has obtained an item license in Korea. The MFDS approved Gavreto 100mg on the 29th. The drug was recognized for its effectiveness in the treatment of ▲RET (RET) fusion-positive local progression or metastatic non-small cell lung cancer adult patients and ▲ systemic therapy required RET mutation local progression or metastatic thyroid medullary cancer for adult patients. The effectiveness is based on the reaction rate and reaction period, and there is no data proving the improvement of the survival period. According to 136 patients who have been administered platinum-based chemotherapy drugs and have been administered Gavreto, the total response rate was 58.8% and the average response duration of 22.3 months. The recommended dosage is 400 mg in adults, which is administered orally once a day. Gavreto obtained conditional approval from the EU Commission in November last year after receiving accelerated approval from the US FDA in September 2020. The FDA approved adult metastatic RET gene fusion-positive non-small cell lung cancer treatments and progressive RET mutation thyroid cancer treatments for children and adults over the age of 12, and the EU applied for permission as a treatment for RET mutated thyroid cancer. Competitive drugs are Lilly's Retevmo 40mg and Retevmo 80mg, and Retvmo was approved from the MFDS on March 11. Retvmo is the first FDA-approved RET inhibitor in May 2020. In Korea, it has indications such as metastatic RET fusion-positive non-small cell lung cancer, progressive or metastatic RET-variant thyroid medullary cancer requiring systemic therapy with previous treatment experience of Sorafenib and/or Lenvatinib. Among domestic pharmaceutical companies, HK inno.N introduced the RET target anticancer drug "VRN061782" from Voronoi in February last year and is conducting commercialization development.
- Company
- First-ever RET inhibitor 'Retevmo' attempts reimbursement
- by Eo, Yun-Ho Mar 31, 2022 05:58am
- The first RET-targeted anticancer therapy is attempting to receive insurance reimbursement in Korea. According to industry sources, Lilly Korea has recently submitted a reimbursement application for its ‘Retevmo (selpercatinib) that targets the RET (Rearranged during transfection)-gene fusions. After receiving approval from the Ministry of Food and Drug Safety through the fast track system, the company has been making progress through the approval-reimbursement linkage system. In 2020, Retevmo was approved as the first treatment option for cancer patients with RET gene alternations in the US after the FDA reviewed the drug through the Accelerated Approval and Priority Review pathway and granted the Breakthrough Therapy & Orphan Drug Designation. Retevmo is indicated for the treatment of:▲ adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC); ▲adults and pediatric patients 12 years of age or older with advanced or metastatic RET-mutated medullary thyroid cancer who require systemic therapy; and ▲ adult patients who are refractory to radioactive iodine therapy and who have prior sorafenib and/or lenvatinib treatment, with advanced or metastatic RET-fusion benign thyroid cancer who require systemic therapy. Retevmo is expected to compete with Roche Korea’s ‘Gavreto (pralcetinib)’ in the future. Gavreto, which has the same mechanism of action as Retevmo, was approved in Korea on the 29th for the treatment of ▲ treat adult patients with RET fusion-positive locally advanced or metastatic NSCLC; and adult patients with RET-mutated locally advanced or metastatic medullary thyroid cancer that require systemic therapy. Professor Byoung Chul Cho of the Yonsei Cancer Hospital’s Lung Cancer Center said, “We had no choice but to conduct chemotherapy in cancer patients with RET gene mutations due to lack of other available treatment options. The approval of Retevmo will become a good alternative for patients who saw relatively low treatment effect from existing chemotherapies and had difficulties due to chemotoxicity.” Meanwhile, Retevmo demonstrated its efficacy through the LIBRETTO-001 trial that was conducted on 702 patients with advanced or metastatic solid cancer with RET mutations. Patients with RET fusion-positive NSCLC, RET-mutated medullary thyroid cancer, and RET fusion-positive thyroid cancer patients with or without prior treatment experience were enrolled in the LIBRETTO-001 trial. The primary endpoints of the trial were the objective response rate (ORR) and duration of response (DOR) as assessed by the independent review committee In patients with RET fusion-positive NSCLC without platinum-based treatment experience, the ORR in the Retevmo-treated group was 85%. Although the median DoR was not yet reached, 79% of the patients showed duration of response during the follow-up period (median 7.4 months). In patients with platinum-based treatment experience, the ORR was 64%, and the median DoR was 17.5 months.
- Policy
- Reimbursement priorities in ultra-high-priced one-shot Txs
- by Lee, Tak-Sun Mar 31, 2022 05:57am
- With the reimbursement imminent for the ultra-high-priced one-shot treatment Kymriah, the National Health Insurance Service is preparing to conduct research on the performance evaluation of the risk-sharing agreement (RSA) and its mid-to-long-term development direction. The research will be exploring ways on the development direction of the RSA system through measures such as setting priorities in the reimbursement of ultra-high-priced one-shot treatments, etc. On the 28th, the NHS made an urgent announcement for a bid on research services for the ' Performance Evaluation of the Risk Sharing Agreement Scheme.’ The research is expected to be completed by November this year after signing a research service agreement in April. In the bid proposal document, NHIS stated, “8 years have passed since the introduction of the risk-sharing system in 2014 to improve access to drug treatment, with no objective evaluation of the effect of the introduction of the system. Also, concerns about the sustainability of insurance finances and the function of v are growing due to the rising demand for reimbursement of ultra-high-priced drugs (one-shot treatments) that can cure patients with a single administration,” indicating the need for research. The purpose of the research is to evaluate the performance of the RSA scheme from a social, economic, and industry aspect and conduct an interview with expert groups to analyze the payable price level for ultra-high-priced drugs, to seek direction on the development of the RSA scheme. To evaluate the performance of the RSA, the research will ▲evaluate the social effect of the RSA scheme (comparison of new drug listing rates pre-and post-implementation to evaluate its influence on patient accessibility, and speed of new drug introduction in Korea) ▲evaluate the economic effect of RSA (assessment of fiscal impact through analysis of RSA drug claims data, assessment of its impact in reducing patient burden, etc.) ▲evaluate the industrial effect of RSA (changes in industry activities in the pharmaceutical industry due to introduction or change of the system, etc.) ▲evaluate the effect of introducing the system from various aspects (including collecting opinions from stakeholders such as academia, patients, medical circles, industry, and government). In order to derive mid-to-long-term improvement plans for the development of the RSA scheme, the research will ▲analyze the pros and cons of the system through a performance evaluation and seek development plans ▲seek improvement plans by examining its operations in other countries ▲seek measures to relieve the administrative burden that increased due to RSA follow-up management such as refunds, etc. In addition, to set priorities for reimbursement and wet standards for the willingness to pay on ultra-high-priced drugs, the research will ▲analyze the reimbursement listing and claims status of ultra-high-priced drugs through an operational definition of the drugs ▲ conduct a focus-group interview (FGI) to survey the experts’ will to pay for ultra-high-priced drugs and seek advice on the considerations that should be made for their reimbursement to set priorities in reimbursement. The NHIS plans to use the research results as evidence for coverage reinforcement policies. In particular, when reviewing the reimbursement listing of ultra-high-priced one-shot drugs that have high social demand, the government will be reflecting the reimbursement priorities’, intention to pay, and other criteria derived from the research into their decision-making process. In addition, the goal is to establish a sustainable management system by preparing effective measures to reduce administrative burdens in the post-management of RSA drugs.
- Company
- Kidney care is also important for diabetic patients
- by Eo, Yun-Ho Mar 30, 2022 06:09am
- SGLT-2 inhibitors, which have obtained indications for chronic kidney disease, are emerging as the mainstay of chronic disease management along with diabetes. According to data from the Korean Diabetes Association, the rate of kidney disease accompanied by type 2 diabetes patients in Korea was about 30%, and one in three diabetes patients in Korea had renal function abnormalities. Studies have also shown that diabetes (40%) is the most common cause of end-stage kidney disease. Diabetes patients have an average annual glomerular filtration rate (eGFR) decrease about twice as quickly as those without diabetes, and the 10-year neoplasia rate for diabetic patients is very low at 40%. Effectiveness of SGLT-2 inhibitors Forxiga, the first diabetic drug in the SGLT-2 inhibition mechanism to obtain an indication for chronic kidney disease, is also drawing attention from domestic medical staff. Forxiga confirmed the benefits of kidney disease in type 2 diabetic patients through a study of DECLARE-TIMI 58. In Forxiga of the DECLARE study, the secondary renal complex evaluation index (decreased by more than 40% eGFR, death from terminal kidney disease, kidney or cardiovascular disease) was 4.3% lower than placebo. The kidney subanalysis of the same clinical trial showed a continuous decrease in eGFR compared to placebo of less than 60 ml/min1.73 m2 by more than 40%, and a 47% reduction in the risk of death from terminal kidney disease or kidney disease. Forxiga confirmed benefits for patients with chronic kidney disease, regardless of diabetes. Jardiance is currently in the process of obtaining a kidney disease indication in the United States. This drug was confirmed to be effective through EMPA-KIDNEY research. The study will be discontinued early according to the recommendation of an independent data monitoring committee while meeting the criteria for positive efficacy. #Sb Society Guidelines also emphasize importance Several domestic and foreign societies first recommend SGLT-2 inhibitors to type 2 diabetes patients with chronic kidney disease in treatment guidelines, emphasizing the importance of integrated management of diabetes and kidney disease. The Korean Diabetes Association recommended that treatments including SGLT-2 inhibitors that have proven cardiovascular and kidney benefits should be considered first if albuminuria exists or the estimated glomerular filtration rate decreases in the 2021 Diabetes Care Guidelines. The American Diabetes Association recommended the use of SGLT-2 inhibitors that demonstrated benefits from heart failure or kidney disease in patients with heart failure or chronic kidney disease in the "2022 Diabetes Guidelines". The European Association for the Study of Diabetes and European Society of Cardiology also recommended SGLT-2 inhibitors as drugs to reduce the progression of diabetic nephropathy in the area of chronic kidney disease management in the "2019 Guidelines for Diabetes, Prediabetes and Cardiology". The KDIGO also recommended combination therapy with metformin and SGLT-2 inhibitors as the primary treatment along with lifestyle correction such as physical activity, diet, and weight loss in patients with chronic kidney disease with glomerular filtration rate of 30ml/min/1.73m2. Kim Dae Joong Professor of Endocrinology at Ajou University Hospital said, "In the long run, exposure to high blood sugar can cause glomerular damage, and proteinuria can occur from a relatively early stage in diabetic patients, so albumin excretion in urine should be measured annually. It is important to evaluate the glomerular filtration rate to determine the degree of abnormalities in new functions," he advised.
- 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.
