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- 2026-03-12 11:15:47
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- Jemperli can be prescribed at general hospitals in KOR
- by Eo, Yun-Ho Mar 11, 2024 05:55am
- Jemperli, the first immuno-oncology option introduced to the field of endometrial cancer, can now be prescribed in general hospitals in Korea. According to industry sources, GSK Korea’s PD-1 inhibitor Jemperli (dostarlimab) has passed the drug committee (DC) reviews of tertiary hospitals in Korea. Including the Seoul National University Hospital and Seoul Asan Medical Center. The company has been gradually expanding its prescribing area after receiving reimbursement for Jemperli in December last year. While the number of hospitals that granted use of the drug is still small, GSK has been working to create an enabling environment for Jemperli prescriptions even before the reimbursement process, implementing an Expanded Access Program (EAP) in 15 major medical institutions in Korea. In the multi-cohort Phase 1 GARNET study that was conducted on patients with recurrent or advanced solid tumors, Jemperli demonstrated efficacy with the Cohort A1 analysis results, which enrolled patients with recurrent or advanced dMMR/MSI-H endometrial cancer who progressed during or after platinum-based systemic chemotherapy. The cohort was among the largest conducted for PD-1 inhibitor monotherapies in advanced dMMR/MSI-H endometrial cancer to date. The primary efficacy outcome measures of the study were Objective Response Rate (ORR) and Duration Of Response (DOR) as determined by a Blinded Independent Central Review (BICR) according to (Response Evaluation Criteria Solid Tumors) RECIST v 1.1. As a result of analyzing a total of 108 patients with a median follow-up of 16.3 months, Jemperli demonstrated durable antitumor activity with a manageable safety profile. In the cohort, the ORR was 43.5% and the median DOR was not yet reached. The Disease Control Rate (DCR) was 55.6%, and the proportions of responses lasting 6 and 12 months were 97.9% and 90.9%, respectively. On the 7th, Jemperli was additionally approved as a first-line treatment in combination with platinum-based chemotherapy for patients with Mismatch Repair Deficient/Microsatellite Instability-High (dMMR/MSI-H) recurrent or advanced endometrial cancer.
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- Hemlibra shows big sales rise, Advate loses ground
- by Kim, Jin-Gu Mar 11, 2024 05:55am
- Hemlibra, introduced to South Korea by JW Pharmaceutical, is a drug used to treat Type A hemophilia. The market for Type A hemophilia has shifted significantly, with JW Pharmaceutical's 'Hemlibra' expanding sales considerably after receiving reimbursement expansion. However, Takeda Pharmaceutical’s 'Advate,' which has been recording the highest sales in the market for an extended period, lost ground. Advate sales decreased by over 20%, recording sales lower than Hemlibra’s. Hemlibra sales KRW 7.6 billion → KRW 19 billion…As a result of acquiring reimbursement expansion According to a pharmaceutical market research company IQVIA on the 8th, the market size of Type A hemophilia last year was KRW 77.1 billion, up 17% from KRW 66.2 billion in 2022. In this figure, sales data from hospitals run by the Korea Hemophilia Foundation were not included. JW Pharmaceutical's Hemlibra sales increased about 2.5 times year-over-year (YoY), surpassing the annual sales of KRW 10 billion for the first time. Its sales last year were KRW 19 billion. Hemlibra, introduced to South Korea by JW Pharmaceutical, is a drug used to treat Type A hemophilia. It utilizes dual-specific antibody technology that binds simultaneously to clotting Factors IX and X. Unlike traditional Factor VIII treatments, Hemlibra is the first non-Factor VIII medication that can be administered subcutaneously up to once every four weeks. JW Pharmaceutical secured the domestic development and sales rights for Hemlibra from Chugai Pharmaceutical in 2017. It acquired Korean BLA in January 2019 and launched in May 2020. After recording KRW 2.1 billion in sales in the first year of launch, its sales expanded to KRW 7.2 billion in 2021 and KRW 7.6 billion in 2022. The significant increase in Hemlibra’s sales last year may be attributed to its reimbursement expansion. Since May, Hemlibra has been reimbursed for ‘patients over the age of one with Type A hemophilia who do not have Factor VIII antibodies.’ In just three years, Hemlibra has expanded its reimbursement for non-antibody patients following its initial insurance coverage for patients with severe Type A hemophilia. Top Type A hemophilia drugs by sales statistics. Moreover, an increase in sales of Hemlibra may be due to its improved administration methods compared to existing treatments. Hemlibra is the first subcutaneous injection formulation, offering patients a more convenient option. Previous treatments required patients to locate a vein and self-administer injections, which was inconvenient and difficult for many patients, especially for children and teenagers. Advate sales, down 22%... Adynovate and Greengene F show weakness in sales overall On the other hand, Takada Pharmaceutical's Advate, which has established a strong position in the market, experienced a significant decrease in sales. Advate's sales last year were KRW 15.1 billion, down 22% compared to KRW 19.5 billion in 2022. Expanding the periods further, it has steadily declined since 2019. Sales of Advate, which stood at KRW 27.7 billion then, decreased to KRW 25.8 billion in 2020, KRW 22.9 billion in 2021, and KRW 19.5 billion in 2022. Advate has demonstrated a strong presence in the hemophilia A market for an extended period. By jointly selling products with GC Biopharma, which significantly influences the domestic hemophilia treatment market, Advate consistently recorded annual sales of over KRW 20 billion. However, Advate is gradually losing its strength as Hemlibra rapidly expands its influence. During the same period, Novo Nordisk Pharma's Novoseven RT sales increased from KRW 5.5 billion to KRW 17.3 billion, exacerbating Advate's decline. Another hemophilia A treatment from Takeda Pharmaceutical, Adynovate, also saw a 20% decrease in sales from KRW 6.8 billion to KRW 5.4 billion. GC Biopharma's GreenMono slightly increased from KRW 6.6 billion to KRW 6.7 billion, while another GC Biopharma's Greengene F, decreased by 35% from KRW 2.7 billion to KRW 1.8 billion. Including joint sales, three out of four products sold by GC Biopharma experienced a more than 20% drop in sales over the past year. However, GC Biopharma is still reported to maintain significant performance in the hemophilia treatment market through the Korea Hemophilia Foundation . The industry expects that Hemlibra's upward trend will continue in the future. This year, we expect to see more prominent effects from expanded reimbursement. It is estimated that there are around 1,700 hemophilia A patients in South Korea. Among them, it is estimated that 60% of non-inhibitor patients with hemophilia A in South Korea are eligible for Hemlibra reimbursement. A critical factor in the current situation is the renegotiation of Hemlibra's reimbursement terms. The risk-sharing agreement (RSA) contract for Hemlibra is scheduled to expire on the 30th of next month. JW Pharmaceutical had previously entered into an RSA contract with the government for Hemlibra, operating under a total expenditure cap model.
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- AZ’s EGPA drug Fasenra receives orphan drug designation
- by Eo, Yun-Ho Mar 11, 2024 05:55am
- AstraZeneca's antibody drug Fasenra has been designated as an orphan drug in Korea for its eosinophilic granulomatosis indication. The Ministry of Food and Drug Safety announced so through an official orphan drug designation notice on the 7th. More specifically, the drug received an orphan drug designation as a treatment for eosinophilic granulomatosis with polyangiitis (EGPA) Fasenra (benralizumab)’s EGPA indication was granted an orphan drug designation by the US FDA in 2018. AstraZeneca recently presented results from its MANDARA trial at the American Academy of Allergy, Asthma, and Immunology (AAAAI) Annual Meeting, showing the drug’s potential. The MANDARA trial is a head-to-head trial that directly compared Fasenra to GSK's antibody drug Nucala (mepolizumab). In the trial, patients with relapsing or refractory EGPA were given one 30mg subcutaneous injection of Fasenra or three 100mg injections of Nucala every four weeks for 52 weeks to compare the efficacy and safety of the two drugs. 140 adults with difficult-to-treat EGPA who were receiving oral corticosteroids, with or without stable immunosuppressive treatment enrolled in the study. The mean age of the patients was 52 years, and 60% were women. Of these patients, 66% had relapsing disease and 60% had refractory disease. Study results showed that the rate of patients who achieved remission at weeks 36 and 48 was 59% in the Fasenra(benralizumab) group and 56% in the Nucala (mepolizumab) group. Although the rate was slightly higher in the Fasenra group compared with the Nucala group, the difference was not statistically significant. However, the results demonstrated Fasenra’s non-inferiority to Nucala. The secondary endpoints, duration of remission and the time to first relapse, were similar in both treatment groups. The mean reductions in blood eosinophil count from baseline to week 52 were comparable between the two groups, the Fasenra group showing reductions from 306.0/µL to 32.4/µL and the Nucala group showing reductions from 384.9/µL to 71.8/µL.1 EGPA is a systemic vasculitis associated with asthma, eosinophilia, sinusitis, pulmonary infiltrates, and neuropathy. EGPA can result in damage to multiple organs, including the lungs, skin, heart, gastrointestinal tract, and nerves, which accumulate over time and can be fatal if left untreated. Fasenra is a monoclonal antibody that binds directly to IL-5 receptor alpha on eosinophils and attracts natural killer cells to induce rapid and near-complete depletion of blood and tissue eosinophils in most patients via apoptosis (programmed cell death). Fasenra is currently approved as an add-on maintenance treatment for severe eosinophilic asthma in the US, EU, Japan, and other countries, and is approved for self-administration in the US, EU, and other countries. In Korea, the drug is being reviewed for reimbursement coverage as a treatment for severe eosinophilic asthma and the agenda has passed the Health Insurance Review and Assessment Service's Drug Reimbursement Evaluation Committee review recently.
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- Anemia drug ‘Vadanem’ makes 2nd attempt at reimb listing
- by Nho, Byung Chul Mar 08, 2024 05:18am
- Mitsubishi Tanabe Pharma Vadanem, Mitsubishi Tanabe Pharma’s new tablet anemia drug, will likely receive approval from the U.S. Food and Drug Administration by early April and make a second attempt at getting a reimbursement listing in Korea. If the company gets the drug reasonably priced comparable to a weighted average price of the substitute during drug pricing negotiation with the Health Insurance Review and Assessment Service (HIRA), the drug will be recorded as the first new anemia drug in tablet form to be commercialized in Korea. According to the pharmaceutical industry, Vadanem (vadadustat) has been re-submitted for U.S. approval for the indication of ‘Treating anemia in adult patients with chronic kidney disease who are receiving dialysis.’ The FDA is conducting a positive review of the submission. Furthermore, listing Vadanem, which received European approval in May 2023, for EU drug pricing is proceeding smoothly. Considering its ongoing FDA approval and European listing schedule, Mitsubishi Tanabe Pharma aims to negotiate with the HIRA for drug pricing within May. However, insurance reimbursement will be available for its known original efficacy in treating anemia in dialysis patients but not in non-dialysis patients. EPO ingredient, developed 30 years ago, is the only new anemia drug available. The products are available as third-generation injection forms with longer administration duration. Increasing demand for new mechanism-based treatments arose due to patients' unresponsiveness to conventional drugs and side effects such as changes in blood pressure and vomiting. Vadanem, which acquired the BLA from the Ministry of Food and Drug Safety (MFDS), is an anemia drug for treating adult patients with chronic kidney disease who are receiving dialysis. It inhibits Hypoxia-inducible factor (HIF) prolyl hydroxylase and promotes Erythropoiesis. HIF is a protein that responds to decreased oxygen supply in cells. When starting Vadanem treatment, patients must have sufficient storage ions and be checked for levels of transferrin saturation (TSAT) and ferritin. The starting reference dose is below 10 g/dL hemoglobin (Hb) for patients who had not previously been treated with erythropoiesis-stimulating agents (ESA). It is possible to switch patients who are receiving ESA to this medication. Vadadustat is orally administered at an initial dose of 300 mg once daily, and after treatment, the dose can be gradually increased depending on the patient's condition. The maximum dose is 600 mg once daily. The need for expedited approval processes for innovative drugs related to kidney disease is driven by the necessity to expand treatment options for patients and reduce health insurance expenses. The number of chronic kidney disease patients in Korea increased by 36.9% from 206,061 in 2017 to 282,169 in 2021, according to data from the National Health Insurance Service (NHIS). Particularly noteworthy is the 82.8% surge among individuals in their 80s during the same period. The number of patients undergoing dialysis is increasing exponentially. The NHIS spends nearly KRW 3 trillion on approximately 100,000 patients. Moreover, patient adherence is expected to increase as Vadanem is an oral tablet, unlike conventional erythropoiesis-stimulating agents that are administered only via injection. Another oral formulation erythropoiesis-stimulating agent similar to Vadanem is JW Pharmaceutical's Enaroy Tab (enarodustat, approved in Korea in 2022). Enaroy Tab is scheduled to undergo reimbursement listing based on the weighted average price of the substitute drug. AstraZeneca's new erythropoiesis-stimulating agent Evrenzo Tab, containing the active ingredient roxadustat, received approval in Korea in 2021. However, due to the company's policy of pricing orphan drugs at a high cost, it seems they have stopped conducting economic evaluations and proposals for a weighted average price of the substitute drug.
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- Oral PNH drug Fabhalta to soon be released in Korea
- by Eo, Yun-Ho Mar 07, 2024 07:15am
- Novartis' new PNH drug Fabhalta is set to land in Korea. According to industry sources, Novartis Korea has submitted an application for the marketing authorization of its Paroxysmal Nocturnal Hemoglobinuria (PNH) drug Fabhalta (iptacopan) to the Ministry of Food and Drug Safety. Therefore, the drug is expected to be approved within this year. After receiving approval from the US Food and Drug Administration (FDA) at the end of the past year, the company is also undergoing review processes for Fabhalta’s approval in Europe and Japan. Fabhalta is a Factor B inhibitor that acts proximally in the alternative complement pathway of the immune system, providing comprehensive control of red blood cell (RBC) destruction within and outside the blood vessels (intra- and extravascular hemolysis [IVH and EVH]). As an oral formulation, the drug offers better dosing convenience over existing intravenous formulations like Soliris and Ultomiris. The drug’s efficacy was confirmed through the Phase III APPLY-PNH trial in patients with residual anemia despite prior anti-C5 treatment who switched to Fabhalta and the Phase III APPOINT-PNH study in complement inhibitor-naïve patients. During the 24-week core treatment periods in the APPLY-PNH and APPOINT-PNH trials 82.3% of anti-C5-experienced Fabhalta patients, 0% of anti-C5-treated patients, and 77.5% of complement inhibitor-naïve patients showed sustained increase of hemoglobin levels of 2 g/dLa or higher from baseline in the absence of transfusions. Also, 67.7% of anti-C5-experienced Fabhalta patients and 0% of anti-C5 patients sustained a hemoglobin level of 12 g/dLa or higher without transfusion. The rate of patients avoiding transfusion was 95.2% for anti-C5-experienced Fabhalta patients and 45.7% for anti-C5-treated patients. The most commonly reported adverse reactions with Fabhalta were headache, diarrhea, abdominal pain, viral infection, and nasopharyngitis. However, a black box warning was included on the risk of serious infections caused by encapsulated bacteria. Meanwhile, competition in the PNH market is expected to intensify in the coming years. AstraZeneca launched Ultomiris (ravulizumab) as a follow-on to Soliris (eculizumab), and Soliris’s patent is due to expire in Europe in 2023 and in the US in 2027. Ultomiris is given intravenously every 2 weeks whereas Soliris is administered every 8 weeks. Roche is also preparing to commercialize crovalimab, which has shown promise in a head-to-head trial with Soliris. The drug recently received the first approval in China and has been designated an orphan drug in Korea. In addition, Samsung Bioepis's Soliris biosimilar ‘Episcli’ recently received approval in Korea. This is the first Soliris biosimilar approved in Korea, and Samsung Bioepis also received approval for the drug in Europe last year.
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- Rare drug Ultomiris posts KRW 40 billion in sales in 3 yrs
- by Nho, Byung Chul Mar 06, 2024 06:03am
- Becoming a KRW 40 billion blockbuster in just 3 years since its launch, the growth potential of AstraZeneca’s Ultomiris Inj (ravulizumab) is gaining industry-wide attention. The biological orphan drug Ultomiris Inj. is considered to be the successor to Soliris Inj. (eculizumab) with significant improvements in dosing convenience. The drug was approved in June 2021 at a reimbursed price of KRW 5,598,942 for the 30 ml vial and is indicated for paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome. By Q3 2021, 2022, 2023, Ultomiris has generated sales of KRW 19.5 billion, KRW 43.1 billion, and KRW 37.8 billion, respectively. Ultomiris is administered every 8 weeks as a maintenance dose (through intravenous infusion 2 weeks after administering a loading dose based on body weight). In contrast, Soliris is dosed with weekly intravenous infusions for the first 4 weeks, followed by a 5th dose 7 days after the fourth dose, and then every 2 weeks thereafter. While Ultomiris is a follow-on to Soliris, it is notable that Soliris still maintains sales as a blockbuster drug that posts sales in the KRW 10 billion range, by securing indications such as systemic myasthenia gravis and neuromyelitis optica spectrum disorder. Soliris had generated KRW 43.8 billion to KRW 43.9 billion in sales in 2019-2020 before the launch of Ultomiris. Since then, it has maintained sales of KRW 31 billion, KRW 10.1 billion, and KRW 6.4 billion through Q3 in 2021, 2022, and 2023, respectively. In addition, Soliris has undergone two drug price cuts from KRW 6,138,844 in February 2017 and is currently priced at KRW 5,132,364 per 30ml vial. PNH is a life-threatening rare blood disease characterized by the destruction of red blood cells by the complement component that is part of the immune system. Without treatment, 4 out of 10 patients die within 5 years after diagnosis. In Korea, around 200 patients suffer from PNH. Until Ultomiris’s launch in Korea in 2012, Soliris was the only treatment for PNH and was shown to improve the 5-year survival rate by 95.5%. Meanwhile, Ultomiris’s efficacy was demonstrated through 2 prospective studies (Study 301 and Study 302) that were conducted on PNH patients. In both studies, Ultomiris demonstrated non-inferiority compared to Soliris in the primary efficacy endpoints of avoidance of the need for transfusions, LDH normalization, and LDH change rate, as well as in the secondary endpoints of LDH change rate, change in the quality of life (FACIT-Fatigue), breakthrough hemolysis, and proportion of patients with stabilized hemoglobin. In addition, a preference assessment study that was conducted as an extension study in patients with paroxysmal nocturnal hemoglobinuria who were previously treated with both Soliris and Ultomiris showed that 93% of patients preferred Ultomiris.
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- Reimb for Verzenio in early breast cancer undergoes review
- by Eo, Yun-Ho Mar 06, 2024 06:03am
- Verzenio, the first CDK4/6 inhibitor to apply for insurance reimbursement in early breast cancer, is taking the second step to extend its reimbursement coverage. According to a report, the agenda of reimbursing Lilly Korea’s Verzenio (abemaciclib) will be presented to the Health Insurance Review and Assessment Service's Cancer Disease Deliberation Committee today (March 6). Therefore, the industry’s attention is on whether Verzenio will succeed in its second reimbursement attempt. The company had difficulty reaching the CDDC stage during its first attempt for reimbursement in early breast cancer. After a long 6-month wait after submitting the application, the case reached the CDDC deliberation stage in May last year, but no standards were set. The company resubmitted the reimbursement application 5 months later to HIRA in October. The same month, a petition was posted on the Cheong Wa Dae National Petition Board, “Petition requesting reimbursement for the targeted therapy Verzenio in early breast cancer.” Also, the application was backed by additional clinical evidence.: 5-year monarchE data that was presented at the 2023 European Society for Medical Oncology (ESMO) Congress. This was a follow-up study to the 4-year data presented at the Annual San Antonio Breast Cancer Symposium Annual and Lancet Oncology in December 2022. Results showed that the gap between the Verzenio arm and the control arm (endocrine therapy alone) in the primary clinical endpoints of invasive disease-free survival (IDFS) and distant recurrence-free survival (DRFS) widened further in year 5 compared to year 4. At year 5, the primary endpoint, the difference in invasive disease-free survival (IDFS), was approximately 8% between the two arms. This suggests that even after completing treatment with Verzenio for a limited period of time, 2 years after the surgery, the treatment benefit continued to year 5. Other than the letrozole generic that is used as endocrine therapy, it is the only new drug available for HR+/HER2- type early breast cancer. The drug’s indication was expanded on November 18th, 2022 as an adjuvant treatment for adult patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-), node-positive, early breast cancer (EBC) at high risk of recurrence in combination with endocrine therapy. More specifically, the drug is indicated for a very limited range of patients with ▲ patients with 4 or more positive axillary lymph nodes, ▲ 1-3 positive axillary lymph nodes, and tumor size of 5 cm or larger, or ▲histological grade 3 disease. Keun Seok Lee, Professor of the Center for Breast Cancer at the National Cancer Center, said, “The Verzenio and endocrine therapy combination is recommended with a high level of evidence in major national and international practice guidelines as adjuvant therapy for patients at high risk of recurrence. With various clinical studies and major academic society reviews confirming its clinical utility, we need to enable rapid access to the treatment through prompt reimbursement to improve the survival of patients at high risk of recurrence.”
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- Cash cow ‘bepotastine’ to face reimb re-evaluation
- by Chon, Seung-Hyun Mar 06, 2024 06:02am
- In facing re-evaluation of ‘bepotastine’ for reimbursement in the upcoming year, pharmaceutical companies fear its impact. The market size for bepotastine has increased by more than 50% in just two years during the pandemic and endemic, labeling bepotastine as a new cash cow. However, there are concerns that the companies may face financial loss if drugs containing bepotastine as an active ingredient receive negative results from the re-evaluation, such as reduced reimbursement or removal. According to industry on the 6th, the Ministry of Health and Welfare (MOHW) recently held the Health Insurance Policy Review Committee, where they reported on drugs that will be re-evaluated for reimbursement appropriateness in 2025. Next year, the reimbursement appropriateness of eight active ingredients, including olopatadine, clematis radix plus trichosanthes root plus prunella spike, bepotastine, spherical adsorptive carbon, artemisia Herb extract, L-ornithine- L-aspartate, and chenodeoxycholic acid-ursodeoxycholic acid, will be determined through the re-evaluation. The MOHW explained, “We have selected eight active ingredients. Five active ingredients have been listed for an extended time, and three active ingredients are currently under clinical re-evaluation by the Ministry of Food and Drug Safety (MFDS)." The MOHW will perform a comprehensive analysis and evaluation of drugs based on clinical research article results, clinical usefulness, cost-effectiveness compared to substitute drugs, and the overall increase in insurance benefits for society. The compiled data will be reviewed by experts, and the MOHW will decide whether to maintain, reduce, or remove reimbursement. The industry is particularly interested in hearing results from the MOHW’s re-evaluation of the appropriateness of reimbursement for bepotastine because the market has expanded significantly recently. Pharmaceutical companies may face financial loss if the drugs containing bepotastine receive negative results from the re-evaluation, such as reduced reimbursement or removal of indication. Annual outpatient prescription sales for bepotastine (unit: 100 million won, source: UBIST). Bepotastine is a drug used to treat perennial allergic rhinitis, chronic hives, and pruritus accompanied by skin disorders. The prescription market for bepotastine experienced rapid growth during COVID-19 and endemic. According to UBIST, a pharmaceutical market research agency, the out-patient prescription market size for bepotastine was 70.2 billion won last year, an increase of 17.7% from the previous year. The prescription market size for bepotastine stayed mainly the same between 2018 and 2021, generating 45.3 billion won and 45.3 billion, respectively. However, it reached 59.7 billion won in 2022, showing a growth of 31.8%, and even greater last year. The prescription market size for bepotastine expanded to 55.2% in the past two years. Since the end of 2021, there has been a significant surge in demand for nasal discharge treatment, which is one of the remedies to alleviate symptoms of COVID-19. This is due to the increasing number of people testing positive for COVID-19, with hundreds of thousands of new cases daily. Even after the pandemic, there are still many COVID-19-positive patients and growing patients with influenza or the common cold, leading to even greater demand for bepotastine. Dong-A Pharmaceutical’s Twolion dominates the prescription market for bepotastine. Twolion’s prescription sales were 10.7 billion won, up 11.7% from the previous year. In two years, it has increased 33.1% from 8.1 billion won in 2021. Mitsubishi Tanabe Pharma’s Talion is the original medicine with bepotastine as an active ingredient. Initially, Dong-A ST marketed Talion, but Mitsubishi Tanabe Pharma withdrew from the Korean market after its patent expired at the end of July. Since then, Dong-A Pharmaceutical received approval for Twolion, a generic version of Talion, and Dong-A ST is responsible for its marketing. Daewon Pharm’s Bepostarbi recorded 4.9 billion won in prescription sales last year, a 29.1% increase in just two years since making 3.8 billion in 2021. Dong Kook Pharmaceutical’s Bepotan accumulated 3.7 billion won in prescription sales, up 47.0% from two years ago. The prescription sales for Medica Korea’s Galion were merely 1.4 billion in 2021 but recorded 3.3 billion won last year, more than doubling the size. Only two of the eight active ingredients survived the reimbursement re-evaluation conducted last year by the MOHW. The MOHW conducted re-evaluation of reimbursement on eight ingredients, including rebamipide, levosulpiride, loxoprofen sodium, limaprost alfadex, epinastine hydrochloride, oxiracetam, acetyl-L-carnitine hydrochloride, and hyaluronic acid (HA) eye drops. Only two of the ingredients, rebamipide and levosulpiride, maintained their reimbursement prices since the drugs proved clinical usefulness. Loxoprofen sodium, limaprost alfadex, and epinastine hydrochloride are the three active ingredients receiving reimbursement cuts. Loxoprofen sodium’s indication, ‘Reducing fever and pain relief for acute upper respiratory inflammation,’ will be excluded from receiving the reimbursement. For limaprost alfadex, the reimbursement will not cover its indication, one of the two, for ‘Improving ischemic symptoms such as ulcer, pain, and cold sensation that are associated with thromboangitis obliterans.’ Oxiracetam and acetyl-L-carnitine hydrochloride were excluded from the current re-evaluation because the MOHW had already stopped allowing reimbursement for those two ingredients due to inadequate demonstration of their effectiveness based on the MFDS’s clinical re-assessment. The decision for hyaluronic acid (HA) eye drops has been postponed until reimbursement criteria for all disposable eye drops are established.
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- Dupixent, 1st biologic approved for pruritic rash indication
- by Son, Hyung-Min Mar 05, 2024 05:49am
- Professor Ahn Ji Young, affiliated with the Department of Dermatology at the National Medical Center. As Dupixent is approved to treat prurigo nodularis (nodular itchy rash), the drug emerged as the only available treatment option among biologic agents. Previously, there were limited treatment options for treating prurigo nodularis, a condition that causes extreme itchiness. Sanofi hosted a press conference at Novotel Ambassador Seoul Gangnam on the 28th to commemorate the company’s expansion of Dupixent indications to treat prurigo nodularis. Dupixent is a biological agent designed to target interleukin (IL)-4 and IL-13 signaling pathway, biomarkers of type 2 inflammation, and regulates the symptoms. The drug has shown effects in inflammatory diseases such as atopic dermatitis and eosinophilic esophagitis. Moreover, Dupixent secured an expanded indication for prurigo nodularis. Last December, Dupixent was approved in Korea for treating moderate to severe prurigo nodularis in patients aged 18 years and older who had inadequate responses to or were not recommended for a topical treatment. Prurigo nodularis is a chronic dermatitis associated with type 2 inflammation. It is known to significantly impact a patient’s quality of life more than any other inflammatory skin disease due to extreme itchiness. High-dosage topical steroids are commonly prescribed for the treatment, but their long-term use can pose safety risks. These risks include dermal atrophy, infection, blurry vision, and vision deterioration. The introduction of Dupixent, which has confirmed efficacy and safety, may improve patient’s quality of life. This approval was based on the PRIME and PRIM2 Phase 3 clinical studies. The studies included 311 patients aged 18 and older with prurigo nodularis. The primary endpoint was the proportion of patients who achieved scores of 4 points or greater reduction in the Worst-Itch Numeric Rating Scale (WI-NRS) at 12 weeks and 24 weeks. In PRIME clinical results, the patients who received Dupixent showed nodule reduction at 12 weeks and 24 weeks. At 24 weeks, 48% of patients with Dupixent showed an improvement in their condition measured by a WI-NRS score of 4 points and a score of 0 or 1 point in the Investigator's Global Assessment PN-Stage (IGA PN-S). Therefore, the improvement by Dupixent treatment was significantly greater than the 18% observed in the placebo group. Furthermore, the PRIME2 clinical study also demonstrated that 45% of patients who received Dupixent showed an improvement by a WI-NRS score of 4 points or more and a score of 0 or 1 point in the IGA PN-S, a significantly higher proportion of patients with improvements compared to the 16% in the placebo group. Throughout the first 24 weeks, Dupixent displayed a consistent safety profile that is similar to what is known from other indications. “Prurigo nodularis is often associated with type 2 inflammatory diseases such as atopic dermatitis and asthma. Almost half of the patients with prurigo nodularis also have atopic disease. Dupixent is the only biologic agent available for targeting this disease,” Professor Ahn Ji Young, affiliated with the Department of Dermatology at the National Medical Center, said. “Over 60% of patients suffer from sleep-related deterioration due to chronic itch, which is often linked to psychological disorders such as depression or anxiety,” Ahn added. “The previous treatment options for prurigo nodularis were limited. Therefore, the introduction of biologic agent that is effective and has fewer side effects can improve the quality of life of the patients,” Ahn emphasized.
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- Kolon Life Science appeals to the Supreme Court for Invossa
- by Nho, Byung Chul Mar 05, 2024 05:49am
- On the 28th, Kolon Life Sciences decided to appeal to the Supreme Court against the manufacturing and sales license revocation ruling that had been made for its knee osteoarthritis cell gene therapy Invossa-K Inj (“Invossa”). In its appeal to the court, Kolon Life Sciences explained, "While we respect the court's decision, we will strive to restore the scientific achievements and value of Invossa, the world's first gene therapy for osteoarthritis, by correcting the misunderstandings that arose regarding the product’s legal principles and safety at the appellate court.” In 2019, Kolon Life Sciences filed an administrative suit to seek the court’s ruling on the illegality and injustice of the MFDS’s decision to revoke Invossa’s marketing authorization but lost both the first and second trials. Kolon Life Sciences acknowledged that there was an error in indicating the origin of the cells for the 2nd liquid, which was the main substance at the time of the application and approval of Invossa. However, since all non-clinical and clinical trials were conducted with the same cells in all stages before its authorization, the company believes the safety and efficacy of Invossa have been verified by the MFDS, and based on which the company plans to continue its vigorous defense in the final appeals following the first and second appeals. Kolon Life Sciences emphasized that the outcome of the administrative proceedings is completely unrelated to the Phase III clinical trial being conducted by Kolon TissueGene in the U.S. and that it decided to proceed with the final trial to correct the misinformation related to Invossa and restore its scientific value. Accordingly, regardless of the outcome of the administrative proceedings, Kolon TissueGene's Phase III clinical trial on TG-C (formerly known as Invossa) in the U.S. is proceeding according to plan. The company is enrolling and dosing 1,020 patients in the U.S., with the last 150 patients enrolled as of January 2024. In addition, TG-C was approved by the U.S. Food and Drug Administration (FDA) in December 2023 to expand its indication to Degenerative Disc Disease (DDD), in addition to being evaluated in Phase II clinical trials for knee osteoarthritis. In October 2023, Kolon Life Sciences was acquitted on appeal in the second trial of a criminal case against company executives who were charged with obstruction of justice against the Ministry of Food and Drug Safety (MFDS), resolving allegations that the company engaged in intentional manipulation and concealment. Long-term follow-up of patients from 2019 to the present has also shown no direct causal relationship between tumor development and treatment with Invossa.
