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- 2026-04-07 13:28:20
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- "Camzyos, reimbursement would benefit gov and patients"
- by Eo, Yun-Ho May 16, 2024 05:48am
- Hyung-Kwan Kim, Professor of the Department of Internal Medicine at Seoul National University Hospital The reason for delayed drug development in a particular disease typically falls into one of two. It’s either low awareness of the disease or challenges to drug development. Despite falling into these two categories, 'Camzyos (mavacamten)' was developed. It is a first-in-class targeted treatment option for obstructive hypertrophic cardiomyopathy (oHCM). oHCM is a rare heart disease characterized by thickened heart muscles that cause narrowing or obstruction of the left ventricular outflow tract (LVOT). Not only does it cause abnormality in heart structure, but it decreases heart function. The symptoms include shortness of breath, chest pain, dizziness, and fainting. It is a fatal disease that could cause cardiovascular complications and sudden cardiac death. Furthermore, there has been a lack of disease-modifying treatment besides short-term management of symptoms. Thus, the development of Camzyos, which works by significantly reducing cardiac myosin actin cross-bridge formation, was exciting news to doctors. However, the concern is whether it could be covered by insurance reimbursement. Although Camzyos was approved in South Korea in May of last year, it has not yet been covered by reimbursement. BMS is pursuing an application for the drug’s listing and is awaiting the review by the Drug Reimbursement Evaluation Committee (DREC) of the Health Insurance Review and Assessment Service (HIRA). Daily Pharm interviewed Hyung-Kwan Kim, Professor of the Department of Internal Medicine at Seoul National University Hospital, about Camzyos’ value and the necessity of reimbursement. -HCM diagnosis has increased following the expansion of reimbursement criteria for cardiac ultrasonography. Has the diagnosis rate increased in the real-world? What is the patient size of HCM in Korea? We don’t have accurate data for Korea yet, but the National Health Insurance Service (NHIS) data shows that the number of patients who are diagnosed with HCM has increased since 2010. Between 2010 and 2016, the number of HCM patients doubled. The increase in diagnosis rate may have been due to the routine health examination in Korea: cardiac ultrasonography can be added to the examination option. This supports the trend since the number of diagnoses has increased, particularly among patients over 50. -It seems that there is a low level of awareness among medical personnel regarding oHCM. In fact, due to the lack of effective treatments for HCM, awareness of the condition has been low, and research has not been very active. Even if someone showed signs of suspected HCM or received a diagnosis, the lack of available therapies meant that coordinated care across tertiary healthcare facilities was almost non-existent. Patients were typically advised to manage their symptoms and avoid strenuous exercise, as no competitive treatment options were available. -The development of Camzyos must be particularly meaningful. Previously, beta-blockers and calcium channel blockers were commonly used to treat oHCM. However, these medications do not target the pathophysiological mechanisms of oHCM, leading to limited effectiveness, and many patients do not experience significant improvement. Disopyramide was previously used but is no longer recommended due to its side effects. Furthermore, since it is not prescribed in South Korea, there are few options for treating oHCM. Medical professionals couldn't help but have high expectations when Camzyos became available. Initially skeptical, I found the clinical data remarkably convincing regarding effectiveness. Even data from patients treated with Camzyos abroad showed significant changes in cardiac ultrasonography findings. Among the seven patients under my care who received Camzyos, almost all showed improvement to the extent that it could be 100%, with effects evident within a month. -The clinical results of Camzyos demonstrated improved exercise capacity in oHCM patients. How significant is this result? Exercise capacity can be categorized into objective measures that can be quantitatively assessed and subjective measures that patients evaluate based on their experience. In clinical studies, Camzyos significantly improved both of these indicators. The subjective indicators of patients currently undergoing Camzyos treatment have also improved across the board. NYHA classification has improved by at least one level, with some cases improving from grade 3 to grade 1. In addition to exercise capacity, cardiac function can be evaluated by checking NT-proBNP levels through blood tests. Among the patients under care, those with elevated NT-proBNP levels at the start of Camgios treatment all experienced decreased NT-proBNP levels. Some patients saw remarkable effects, with NT-proBNP levels dropping from 2,000 to 3,000, within the normal range after just one month of Camzyos treatment. -Last year, the European Society of Cardiology (ESC) updated its guidelines for the management of cardiomyopathy for the first time in about 9 years since 2014, adding recommendations for the treatment of Camzyos. What do you think about this? It's promising. I had hoped it would be recommended as a first-line treatment, but ESC seemed to take a conservative approach. Considering the nature of ESC guidelines, where first-line recommendations are not often made right away, there is ample possibility for Camzyos to be recommended as a first-line therapy in the future. -It sounds like Camzyos could possibly be a first-line treatment. Yes. Considering the pathophysiological mechanism of oHCM, I believe it is important for Camzyos to become the first-line treatment option in the long term. This way, we can reduce the unnecessary time and medical expenses of patients who use ineffective medication for 2-3 months. -The concern is that Camzyos is still a non-reimbursed drug. There must be disappointments in the real-world. oHCM is associated with a higher risk of stroke because atrial fibrillation and aneurysms of the left ventricle are not uncommon even in younger age groups. In the case of a oHCM patient in his late 40s, who had no symptoms at all, an aneurysm was found in a screening test conducted every 2-3 years. Currently, in Korea, NOACs (new oral anticoagulants) cannot be used to prevent stroke with aneurysms alone, and warfarin must be used, which requires continuous monitoring when administering warfarin, which is very difficult. So, I explained to the patient that I thought oHCM caused the aneurysm and suggested surgery or treatment with Camzyos. In the end, the patient opted for Camzyos treatment, and within one month, what appeared to be a pericardial aneurysm improved, and the condition of the heart that had been obstructed improved. If he hadn't been treated for Camzyos, his aneurysm would have become stuck, increasing his risk of stroke, and he would have been forced to stay in the hospital and suffer from shortness of breath while being treated with ineffective medications. If Camzyos is covered by reimbursement, patients with similar difficulties will be able to receive many benefits and help. However, it seems that there are many difficulties in discussing reimbursement adequacy with previous treatment options as a comparison. In the real-world practice of medicine, many patients are unable to take their medications due to high non-reimbursement costs and are just waiting for reimbursement. -Camzyos is awaiting the DREC review. As mentioned before, medical personnel voice that there are no comparable treatments to Camzyos. What should government consider when determining the reimbursement? From a short-sighted point of view, reimbursement listing of a drug may seem like a disadvantage in health insurance finances, but if we expand our view on a macro level, we can see that this is not the case. If left untreated, patients with oHCM are at increased risk of developing heart failure, which inevitably increases the direct and indirect health care costs. In addition, an aneurysm increases the risk of stroke, which adds the cost of hospitalization to the cost of stroke medication. These costs can be considered in the long run as more patients are treated with Camzyos before complications occur. If their condition improves, the additional costs associated with emergency room admissions and treatment for other complications can be reduced. Ultimately, patients, doctors, and health authorities can benefit from each other.
- Policy
- Multiple sclerosis drug Ocrevusis approved in Korea
- by Lee, Hye-Kyung May 14, 2024 05:48am
- The Ministry of Food and Drug Safety (Minister: Yu-Kyung Oh) announced on the 13th that it has approved Roche Korea’s orphan drug Ocrevus (ocrelizumab) for multiple sclerosis (MS) in Korea. Multiple sclerosis is a chronic condition that develops in the central nervous system, which consists of the brain, spinal cord, and optic nerves and is an autoimmune disease in which the patient's immune system attacks the body’s healthy cells and tissues. Ocrevus Inj is a recombinant humanized monoclonal antibody (mAb, IgG1) that selectively targets CD20-expressing B cells, reducing the number and function of B cells to inhibit MS. The initial dose is 600 mg divided into 2 intravenous infusions, followed by a single 600 mg intravenous infusion every 6 months. Ocrevus was approved by the US FDA in March 2017 for the treatment of adult patients with relapsing or primary progressive forms of multiple sclerosis. At the time of its initial approval, Ocrevus was approved for twice-yearly dosing following 2 two-week induction therapies. The drug was then additionally approved in December 2020 to reduce the dosing time to 2 hours from 3.5 hours. Ocrevus is the top-selling drug for multiple sclerosis, posting sales of USD 6.27 billion (KRW 8 trillion) in 2020. The MFDS said, "We expect this drug to provide a new treatment opportunity for patients with relapsing-remitting and primary progressive MS. We will continue to do our best to ensure that treatments with sufficiently verified safety and effect are promptly supplied based on our regulatory science expertise.”
- Policy
- BIO KOREA 2024 concludes a success
- by Lee, Hye-Kyung May 14, 2024 05:48am
- BIO KOREA 2024, cohosted by the Korea Health Industry Development Institute (President: Soon-do Cha) and the Provincial Administration of Chungcheongbuk-do (Governer: Young-hwan Kim), concluded successfully on the 10th. BIO KOREA 2024, which celebrates its 19th anniversary this year, was held for 3 days at COEX in Seoul under the theme of 'The Future of Biotechnology Innovation and Global Collaboration. Pic of BIO KOREA 2024 event At the event, participants shared the trends and prospects of innovative technologies that have recently attracted attention in the biohealth industry. The event also provided opportunities for global companies, institutions, researchers, and investors needed for the successful development of these technologies to forge business partnerships. 55 countries, 707 companies, and over 30,000 people attended the event. In a congratulatory speech at the opening ceremony, Minister of Health and Welfare Kyoo-HongChosaid, "We will continue to expand R&D support, create a mega fund, support exports, and foster specialized talent for the goal of making the leap and becoming a global biohealth hub. We expect BIO KOREA to spark cooperation for open innovation for Korean innovative businesses with innovative technologies of the future generation to expand their presence in the global market.” The event included business partnering, investment fair, exhibition, and conference programs. In the business partnering program, which had been expanded due to increased demand for meetings following the participation of leading domestic and international biohealth companies, more than 1,800 meetings were held over 3 days to explore various business opportunities such as finding new partners, discussing technology cooperation and joint research, technology transfer, and investment. The number of overseas participants attending to discover excellent domestic technologies increased by about 25% from the previous year, and the number of meetings held increased by about 36% in the same period. The number of overseas companies participating in the exhibition increased by 37% , and 81 local companies from 10 countries participated in the National Pavilion and actively discussed business opportunities with domestic companies. The conference featured 11 sessions that introduced and shared the latest advances and technology trends in the biohealth industry, including next-generation drug discovery platforms, diabetes and obesity treatments, microbiomes, and global open innovation. The conference hall was filled with attendees showing great interest in the special sessions on next-generation drug discovery platforms, diabetes and obesity drugs that are gaining explosive interest and demand, and AI new drug development. KHIDI President Soon-Do Cha remarked, “Thanks to the interest and active participation of domestic and international companies, organizations, and stakeholders, the BIO KOREA 2024 has concluded smoothly. We hope that BIO KOREA will continue to serve as the largest technology and business exchange venue in Korea where Korean companies can forge global partnerships and create new business opportunities."
- Opinion
- [Reporter’s View] MFDS’ Regulatory Innovation 3.0
- by Lee, Hye-Kyung May 14, 2024 05:48am
- The Ministry of Food and Drug Safety (MFDS)’s announcement of the regulatory innovation tasks is now an annual event. The Regulatory Innovation 1.0, announced just two months after Oh Yu-kyoung’s appointment as the minister, focused on regulations that need system improvements. Since 1.0 was criticized for not considering citizens’ opinions, 2.0 announced tasks, including managing digital safety, increasing consumer and small business benefits, and supporting future businesses. What about the implementation rate? The Regulatory Innovation 1.0, which included 100 tasks in three fields as part of the 'Improvement of Safety and Enhancement of Convenience for Health Functional Food,' had 88% implementation rate. 'Regulatory Innovation 2.0 Tasks for Food and Drug' solved 65 out of 80 tasks in five fields, showing 81.3% implementation rate. Both projects achieved over 80% implementation rate in a year. On May 2, the Regulatory Innovation 3.0 was announced. Unlike previous regulatory innovation announcements that felt like a mandatory annual event, 3.0 was different. Previous announcements lacked innovative tasks related to pharmaceuticals despite their intentions to include both food and drugs. While 1.0 and 2.0 merely updated old regulations, 3.0 aimed to solve regulations essential to the field. 3.0 included regulatory innovation tasks that would meet the needs of the pharmaceutical industry. After the Regulatory Innovation 3.0 announcement, the MFDS also provided a separate session for the pharmaceutical industry, sharing 3.0’s policy and agenda related to the field of pharmaceuticals. This year, there will be significant changes to the GMP evaluation policy, the department of approval, the clinical trial system, and the post-management of drugs. After the 3.0 announcement, there was significant interest from the pharmaceutical industry regarding the revision of requirements for registering APIs. The GMP evaluation for APIs will be replaced with documents proving the country of origin and PIC/S countries. The MFDS is already discussing internally to revise the regulation related to GMP within this year. They will announce the legislation this month and set a goal to implement the revision by December after hearing experts’ opinions and the review by the Office for Government Policy Coordination. The revision will be made so that facility audits will be substituted with submitting documents for GMP evaluation of APIs starting next year. There were doubts when Regulatory Innovation 1.0 was announced three years ago, but now the industry looks forward to the announcement of 4.0.
- Company
- New oral psoriasis drug 'Sotyktu' available in hospitals
- by Eo, Yun-Ho May 14, 2024 05:48am
- BMS Korea’s Sotyktu (deucravacitinib). An oral psoriasis drug 'Sotyktu' is becoming available for prescription at general hospitals. According to industry sources, BMS Korea’s Sotyktu (deucravacitinib) has passed the drug committee (DC) of hospitals, including Seoul Asan Hospital, Severance Hospital, Konyang University Hospital, Soonchunghyang University Bucheon Hospital, Seoul National University Bundang Hospital, Soonchunghyang University Hospital Seoul, Ewha Womans University Medical Center, Chosun University Hospital, and Soonchunghyang University Cheonan Hospital. Sotyktu is expanding its prescription areas after being listed for insurance reimbursement in April. Sotyktu is the first TYK2 inhibitor approved for adults with moderate-to-severe plaque psoriasis. It has been 8 years since the approval in August of last year in South Korea for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy. It is now covered by health insurance. It is covered by insurance reimbursement for the treatment of patients over 18 with chronic severe plaque psoriasis who have symptoms lasting over six months. Coverage requirements include ▲Plaque psoriasis with over 10% of the total skin areas ▲Patients who have Psoriasis Area and Severity Index (PASI) score of over 10 ▲Patients who have undergone methotrexate or cyclosporine for over 3 months but cannot continue the treatment due to no response or side effects ▲Patients who have undergone light therapy or UPV photo therapy for over 3 months but cannot continue the treatment due to no response or side effects. Clinical efficacy of Sotyktu was demonstrated in Phase 3 POETYK PSO-1 and POETYK PSO-2 clinical studies, which compared the drug with placebo or Otezla in 1,684 adult patients aged 18 or over with plaque psoriasis. POETYK PSO-1 studies have shown that the Sotyktu treatment group had a PASI 75 response rate of 58.4% at week 16, which was significantly higher than the apremilast group’s 35.1% and the placebo group’s 12.7%. Furthermore, 53.6% of the Sotyktu treatment group achieved sPGA score of 0 or 1, higher than 32.1% in the apremilast group and 7.2% in the placebo group. In POETYK PSO-2 study, the Sotyktu treatment group had a PASI 75 response rate of 53.0% at week 16, which was significantly higher than the apremilast group’s 39.8% and the placebo group’s 9.4%. Furthermore, 49.5% of the Sotyktu treatment group achieved sPGA score of 0 or 1, higher than the apremilast group’s 33.9% and the placebo group’s 8.6%. Sotyktu’s high response was maintained up to 52 weeks. Choe Yong-beom, President of Korean Society for Psoriasis, said, "Previously, patients who did not respond to or have had side effects when treated with conventional treatments, such as systemic therapy or light therapy, had biological agents as their only option. Sotyktu, which offers the convenience of once-daily oral administration, is expected to meet the unmet needs of psoriasis patients.”
- Company
- Ryvrevant to lead market with Exkivity’s market withdrawal
- by Son, Hyung-Min May 14, 2024 05:48am
- Takeda Exkivity, a treatment for non-small-cell lung cancer patients with EGFR exon 20 insertion mutation, is being withdrawn from the market. The highly anticipated oral treatment failed to demonstrate efficacy in a confirmatory clinical trial, leading to its market withdrawal. With no competition, Rybrevant is expected to remain the market leader for the foreseeable future. According to industry sources on April 4, Takeda withdrew the market approval for Exkivity as of the first of this month. Takeda’s Exkivity was approved in Korea in July 2022 to treat patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutation. However, Exkivity was withdrawn from the Korean market after nearly 2 years due to the failure of the confirmatory trial that was required to maintain the license. While there are many targeted therapies for EGFR-positive lung cancer that target exon 19 and exon 21, such as Tagrisso and Leclaza, targeted therapies for EGFR exon 20 insertion mutations have been difficult to develop. The exon 20 insertion variant is known to have many subtypes, making it difficult to target. Hanmi Pharmaceutical's poziotinib also failed to demonstrate efficacy in a Phase II trial. Takeda received approval for Exkivity based on efficacy results of the Phase I/II AP32788-15-101 trial which enrolled 114 patients with EGFR Exon20 insertion mutation-positive NSCLC. In the trial, patients treated with Exkivity showed an objective response rate (ORR) of 28%. Also, as an oral drug, Exkivity owned the advantage of being easier to administer compared to competing products. However, Exkivity failed to demonstrate efficacy in the Phase III trial. The Phase III EXCLAIM-2 trial compared the efficacy and safety of Exkivity with platinum-based chemotherapy in treatment-naïve patients with EGFR exon 20 insertion mutation-positive locally advanced or metastatic NSCLC. Results showed that Exkivity did not improve progression-free survival (PFS), the primary endpoint, compared to platinum-based chemotherapy. As a result, Takeda has decided to withdraw Exkivity from the global market, including in Korea. Rybrevant becomes the only treatment to target exon 20 insertion mutation Janssen With the voluntary withdrawal of Exkivity from the market, Janssen's Rybrevant will become the only treatment available for EGFR exon20 insertion mutation-positive NSCLC. Ryvrevant was approved in February 2022 for the treatment of patients with locally advanced or metastatic NSCLC whose disease progressed during or after treatment with platinum-based chemotherapy. Although Rybrevant was approved as a second-line treatment, there is a high likelihood that the drug will additionally be approved as a first-line treatment in Korea. The U.S. Food and Drug Administration (FDA) recently approved Rybrevant plus platinum-based chemotherapy as a first-line treatment, and the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of the combination as a first-line treatment in Europe as well. Rybrevant demonstrated its efficacy in the Phase III PAPILLON study. The study enrolled 308 patients with previously untreated EGFR exon20 insertion mutation-positive advanced NSCLC. The study also included patients with a history of brain metastases. Results showed that Rybrevant plus platinum-based chemotherapy (carboplatin+pemetrexed) reduced the risk of disease progression or death by 61% compared to chemotherapy alone. The ORR was 73% in the Rybrevant combination arm and 47% in the chemotherapy arm. Adding on to its list of strengths, Rybrevant also has Leclaza. The target therapy combination of Rybrevant, which targets EGFR exon 20, with Leclaza, which targets exons 19 and 21, has demonstrated efficacy recently. In the MARIPOSA trial, Leclaza plus Rybrevant met the primary endpoint and demonstrated efficacy compared with Tagrisso. In addition to MARIPOSA, which evaluated the efficacy of the combination therapy, the PALOMA study is evaluating the efficacy and safety of the subcutaneous Rybrevant combination and Leclaza. To date, clinical results that have been published have shown that the subcutaneous formulation of Rybrevant is well tolerated compared to the intravenous infusion. The Rybrevant subcutaneous injection can be administered in 7 minutes. This is why attention is rising on whether the combination therapy will address the concerns of infusion-related reactions (IRRs) reported in the MARIOSA study with the use of the Rybrevant SC formulation.
- Policy
- New dementia drug Leqembi’s approval imminent in Korea
- by Lee, Hye-Kyung May 14, 2024 05:48am
- The marketing authorization for Leqembi (lecanemab), the first drug to slow the progression of Alzheimer's disease, is imminent in Korea. According to industry sources on the 14th, the Ministry of Food and Drug Safety (MFDS) completed the safety and efficacy review of ‘Leqembi (lecanemab),’ a new drug for Alzheimer's disease that was co-developed by the Japan-based Eisai and US-based Biogen. The safety and efficacy review is the final step in Korea’s approval process, and as long as there are no serious issues during the review, the drug is granted marketing authorization. If the drug’s official approval is announced in Korea soon, Korea will become the 4th country in the world to approve Leqembi, following the United States (July 2023), Japan (September 2023), and China (January 2024). Currently, ‘donepezil,’ ‘galantamine,’ ‘rivastigmine,’ and ‘memantine' are used to treat dementia, including Alzheimer's disease, but all are only able to relieve symptoms such as cognitive impairment and do not fundamentally slow the progression of dementia. Therefore, a dire need existed for a new drug that fundamentally delays dementia by removing abnormal 'amyloid' and 'tau', which are known to be the cause of Alzheimer's disease. After Eisai and Biogen’s Aduhelm (aducanumab) received conditional approval in June 2021, Leqembi received FDA approval last year, opening up the possibility of a new treatment market for Alzheimer's. In the Clarity-AD study, Leqembi was shown to delay cognitive decline by 27% after 18 months of treatment in 1,795 patients, with a 0.45 point less change in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) compared to placebo. Based on these results, if and when Leqembi is approved, its indication in Korea, is expected to be for the ‘treatment of mild cognitive impairment due to Alzheimer's disease and early Alzheimer's disease’ like by the FDA. Leqembiis administered to patients as an intravenous infusion once every two weeks. Leqembi has been proven to reduce the rate of disease progression and slow cognitive decline by selectively binding to amyloid beta (Aβ) aggregates, which are a known cause of Alzheimer's disease. However, in the case of amyloid-targeted therapies, amyloid-related imaging abnormalities(ARIA), which are abnormal signals such as brain edema or microhemorrhage observed on MRI scans, may occur with their use. Although the first new Alzheimer's drug is expected to be commercialized in Korea, the biggest obstacle to its use is its drug cost. Leqembi costs about KRW35 million per year in the U.S. and KRW 27 million in Japan. Since this means it would cost tens of millions of won to slow down the progression of mild dementia, Korean patients are forced to wait for it to be covered by insurance. Even if a new drug is eventually introduced, it will take a lot of time, including drug pricing negotiations, before it can be used by patients. Meanwhile, companies in Korea are also steadily developing Alzheimer's drugs. According to the 'Development of Diagnosis and Treatment for Alzheimer's Disease Report’ that was published by KoreaBIO in 2022, GemVax & Kael, CHA Biotech, AriBio, D&D Pharmatech, ABL Bio, Oscotecc are currently developing new drugs for dementia. Recently, Dong-A ST received approval to conduct a Phase 1 clinical trial for 'DA-7503', an Alzheimer's treatment that inhibits tau aggregation. However, many potential Alzheimer's drugs have failed to overcome the barrier of clinical trials. In 2007, Kwang Dong Pharmaceutical advanced its natural product dementia drug ‘KD501’ to Phase II clinical trials, but in 2019, it put the development on hold. CHA Biotech also conducted a domestic Phase 1/2a clinical trial of its stem cell therapy-based Alzheimer's drug ‘PlaSTEM-AD’ in 2019, but no news has been heard of its results.
- Company
- AbbVie’s Aquipta becomes the first oral CGRP migraine drug
- by Son, Hyung-Min May 13, 2024 05:52am
- Professor Byung-Kun Kim (Department of Neurology, Nowon Eulji Medical Center) For the first time, an oral CGRP drug has been introduced for the treatment of migraine. AbbVie’s Aquipta has shown positive results as a preventive treatment for chronic migraine as well as episodic migraine in patients who have failed up to 4 prior oral preventive treatments. Experts believe that the benefits of being an oral formulation would allow Aquipta to become a viable new treatment option that can meet the unmet needs of migraine patients in Korea. On the 10th, AbbVie Korea held a press conference to celebrate the launch of Aquipta, its oral calcitonin gene-related peptide (GRRP) receptor agonist, in Korea. Aquipta was approved in Korea last November for migraines in adults. The drug was approved by the U.S. Food and Drug Administration (FDA) in 2021 as a prophylaxis of adult episodic migraine and chronic migraine and in August last year in Europe for the prevention of migraine in adult patients with 4 or more migraine days per month. The domestic approval was based on the Phase III PROGRESS, ADVANCE, and ELEVATE studies. The PROGRESS trial compared the efficacy and safety of Aquipta with placebo in the prevention of chronic migraine. The study enrolled 521 adult patients with a history of chronic migraine (15 or more migraine days per month and at least 8 migraine days per month) for at least 1 year, who were randomized 1:1 to either the Aquipta or placebo arm. The primary endpoint was the change from baseline in the mean migraine days per month during the 12-week treatment period. Results showed a 6.9-day reduction in mean migraine days per month from baseline in the Aquipta arm, compared to 5.1 days in the placebo arm. The ADVANCE trial evaluated the efficacy of Aquipta versus placebo in the prevention of episodic migraine. The study enrolled 458 adult patients with a history of episodic migraine, defined as 4 to 14 migraine days per month. Results showed that the mean number of migraine days per month was reduced by 4.2 days from baseline in the Aquipta arm and 2.5 days in the placebo arm. Also, in the ELEVATE study, which evaluated the prevention of episodic migraine in patients who had failed prior preventive treatments, Aquipta achieved a greater reduction in mean monthly migraine days compared to placebo. Professor Byung-Kun Kim (Department of Neurology, Nowon Eulji Medical Center) said, “The introduction of CGRP receptor antagonists has shown great effect in preventing migraines. However, existing drugs are injectables that require monthly visits to the clinic. So the introduction of an oral option has broadened the pool of treatment options for our patients." “Migraine waxes and wanes over time, so it is very difficult to prove the effectiveness of a new drug over placebo in the area. The fact that Aquipta has demonstrated efficacy in more than 500 patients is meaningful. Clinical trials do not take into account whether migraine patients can conduct their daily lives. With the use of CGRP receptor agonists, we received feedback from patients that they can go about their daily lives. This is an important factor to consider." Migraine severely impacts daily life...' reimbursement standards need to be improved’ Professor Min Kyung Chu (Department of Neurology, Severance Hospital and Chair of the Korean Headache Society) According to the World Health Organization (WHO), migraine is one of the top 10 conditions that reduce quality of life. According to the 2019 Global Burden of Disease Study, migraine was the second leading cause of disability and the first leading cause of death among women under 50 years of age. In fact, the number of migraine patients is on a constant rise. According to the Health Insurance Review and Assessment Service, the number of migraine patients in Korea increased by 10.5% from 545,607 in 2018 to 602,906 in 2022. While some patients with mild headaches can go about their daily lives, others suffer from symptoms such as nausea, photophobia, phonophobia, and osmophobia. Also, their condition is often accompanied by pain in the eye area, and the migraine attacks may last for more than a day. Professor Min Kyung Chu (Department of Neurology, Severance Hospital) said, “If you have over 3-4 migraine attacks a month, or develop 1-2 migraine attacks a month, you need aggressive preventive treatment. Although costly, CGRP-targeted therapies have changed the landscape of migraine treatment, bringing great benefits to the patients.” Professor Chu added, “Due to strict reimbursement standards set for the use of CGRP treatments in migraines in Korea, more than 90% of the existing CGRP drugs are prescribed without reimbursement. If one drug fails, we need to switch to a different drug, but Korea’s current reimbursement standards do not allow switching between CGRP drugs. Many areas are in need of improvement, and we plan to continue to raise this issue at the academic level as well."
- Company
- BeiGene reapplies for Tevimbra’s reimb in esophageal cancer
- by Eo, Yun-Ho May 13, 2024 05:52am
- BeiGene is again attempting reimbursement for its immunotherapy, ‘Tevimbra (tislelizumab)’ in Korea. According to industry sources, BeiGene Korea recently submitted an application for the reimbursement of its Tevimbra (tiselizumab) and is waiting for the Health Insurance Review and Assessment Service's Cancer Disease Review Committee’s deliberation. Tevimbra had previously received the ‘reimbursement standards not set' decision by the CDDC in March. Therefore, the industry’s eyes are on whether the company’s second attempt for Tevimbra's reimbursement will be successful. Tevimbra (tiselizumab), which was approved in Korea last November, is an immuno-oncology drug indicated as a monotherapy for patients with unresectable, relapsed, locally advanced, or metastatic oesophageal squamous cell carcinoma who are unable to continue platinum-based chemotherapy or who have relapsed or progressed after receiving prior platinum-based chemotherapy. In the global Phase III RATIONALE-302 trial, Tevimbra prolonged median overall survival (OS) by 2.3 months compared to chemotherapy (8.6 months vs. 6.3 months), with a statistically significant 30% reduction in the risk of death, and did not show any crossover, unlike existing immuno-oncology monotherapies in the OS graph. In the trial, Tevimbra’s OS improvement was consistent across predefined subgroups, including baseline PD-L1 status, region, and race. Compared to chemotherapy, Tevimbra resulted in more than twice as many patients responding to treatment (20% vs. 10%), and showed an improvement in the median duration of response of approximately 3 months, from 4.0 months to 7.1 months, with sustained responses and a reduction in tumor size, which is directly related to quality of life for esophageal cancer patients. Furthermore, Tevimbra was associated with a 17% lower risk of disease progression or death in progression-free survival (PFS) (HR=0.83, 95% CI 0.67-1.01) and improved health-related quality of life (HRQoL) compared to chemotherapy. In April, the U.S. National Comprehensive Cancer Network (NCCN) revised its guidelines to recommend Tevimbra as a Category 1, preferred option for second-line treatment of esophageal squamous cell carcinoma.
- Company
- MM drug Tecvayli can be prescribed in tertiary hospitals
- by Eo, Yun-Ho May 13, 2024 05:52am
- The new multiple myeloma drug ‘Tecvayli’ can now be prescribed in tertiary hospitals in Korea. According to industry sources, Janssen Korea’s multiple myeloma drug Tecvayli (teclistamab) has passed the drug committee (DC) review of top tertiary hospitals in Korea, including Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, and Seoul Asan Medical Center. After being approved in Korea in July last year, Tecvayli may be prescribed to treat patients with relapsed or refractory multiple myeloma who have received at least three previous lines of treatment, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy. Tecvayli is the first bispecific antibody that induces apoptosis, by binding to 2 receptors commonly found on multiple myeloma cells. Multiple myeloma is a blood cancer caused by the abnormal differentiation and proliferation of B cells (plasma cells), a type of white blood cell responsible for the immune system located in the bone marrow. It is the second most common blood cancer, with most patients experiencing relapses. Tecvayli binds to the B-cell maturation antigen (BCMA) on myeloma cells, and CD3 on T-cells. Tecvayli binds to BCMA and CD3 and induces myeloma cell death via redirection of T cells. Tecvayli was approved based on results from the Phase 1/2 MajesTEC-1 study. In the trial which evaluated the efficacy and safety of the drug in a total of 165 patients, Tecvayli achieved an overall response rate (ORR) of 63% in patients with relapsed or refractory multiple myeloma (RRMM) who have received three or more therapies, including triple-class exposure to a proteasome inhibitor (PI), an immunomodulatory drug and an anti-CD38 monoclonal antibody. Also, 32.7% of the patients achieved a stringent complete response (sCR). Also, 6.7% and 19.4% of patients showed a complete response (CR) and very good partial response (VGPR), respectively. The median time to first response was 1.2 months, and the duration of response (DOR) was analyzed to be 18.4 months (14.9-not estimable). Ki-Hyun Kim, Chairman of the Multiple Myeloma Research Committee at the Korean Society of Hematology (Hematology-Oncology, Samsung Medical Center), said, “Based on the high response rate and the convenience of being an off-the-shelf, patient-administered formulation, we believe that the bispecific antibody Tecvayli may provide significant clinical benefit and hope for patients with multiple myeloma.”
