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- 2025-12-22 07:37:45
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- New PAH drug Winrevair to land in KOR next year
- by Eo, Yun-Ho Dec 13, 2024 05:52am
- The new pulmonary arterial hypertension drug ‘Winrevair’ is expected to be commercialized in Korea soon. According to industry sources, MSD Korea's Winrevair (sotatercept), the world's first symptomatic treatment for pulmonary arterial hypertension, recently passed the second approval-reimbursement linkage evaluations. The drug’s formal approval is expected in 2025. Winrevair had been designated as an orphan drug by the Ministry of Food and Drug Safety in January, then designated as a Global Innovative products on Fast Track (GIFT) in April this year. In March, the US FDA approved Winrevair for the treatment of pulmonary arterial hypertension as a subcutaneous injection administered once every three weeks. Winrevair is a combination of the protein complex activin with the transforming growth factor TGF-β. It works by blocking abnormal signaling between pulmonary vascular cells to reverse disease progression. Pulmonary arterial hypertension is a condition in which the blood vessels in the lungs narrow, causing high pulmonary blood pressure, which leads to heart failure. In Korea, about half of patients die within 5 years. More than 10 drugs have been approved in the area, including phosphodiesterase-5 inhibitors and endothelin receptor antagonists, but many patients suffer from severe symptoms despite using 2 to 3 drug combinations. In Phase III STELLAR study, sotatercept demonstrated efficacy over placebo. In the trial, patients were randomized 1:1 to sotatercept or placebo to assess the efficacy and safety of the drug. Results showed that sotatercept increased the 6-minute walk distance (6MWD), the primary endpoint, by 40.1 meters compared to a 1.4-meter decrease found with placebo over the same period. 38.9% of patients that used sotatercept met the secondary composite endpoint, which included an improvement of 30 meters or more in the 6-minute walking test. This was 4 times longer than that of the 10.1% in the placebo group.
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- "Confirmed long-term Tx effects of Camzyos…new oHCM Tx"
- by Son, Hyung Min Dec 13, 2024 05:51am
- Dr. Neal K. Lakdawala, Professor at Brigham and Women "In a clinical study spanning three years, Camzyos has demonstrated consistent patient symptom management and safety in many patients with obstructive hypertrophic cardiomyopathy (oHCM). Given its proven efficacy in long-term treatment, it is expected that many patients with oHCM can significantly improve their quality of life through this treatment without the need for surgical treatment." During a recent meeting with Daily Pharm, Dr. Neal K. Lakdawala, Professor at Brigham and Women's Hospital in the United States, remarked on 'Camzyos,' a first-in-class targeted treatment option for obstructive hypertrophic cardiomyopathy (oHCM), as above oHCM is a type of hypertrophic cardiomyopathy (HCM) characterized by abnormal heart muscle thickening, primarily in the left ventricle. This condition obstructs blood flow and impairs heart function. Common symptoms include shortness of breath, chest pain, and fainting, and it can lead to complications such as heart failure, atrial fibrillation, and even sudden cardiac death. Until now, treatment methods besides surgical treatment because no treatments could directly target pathophysiological causes of oHCM. While unmet needs for oHCM have been high, the introduction of Camzyos as the first treatment targeting the pathophysiology of the disease has opened the gate for new treatment options. Camzyos is a treatment for oHCM that reduces excessive cross-bridge formation between actin and myosin in the heart muscle, which is the underlying cause of the condition. This mechanism helps relax the overly contracted heart muscle. Additionally, the therapy has demonstrated myocardial remodeling effects, improving not only the function of the heart but also its structural integrity. Camzyos can be reimbursed with the national health insurance starting this month in South Korea. Now, Korean patients with oHCM can use targeted treatment options besides the option of surgical treatment. Dr. Lakdawala remarked that Camzyos could change the treatment paradigm for oHCM since the drug's efficacy and safety were demonstrated not only in clinical trials for approval but also in long-term administration studies. Camzyos demonstrates consistent effectiveness in long-term administration studies In the EXPLORER-HCM trial, which was the basis for approval, Camzyos demonstrated significant improvement in the primary endpoint, which assessed both symptom severity (NYHA class) and exercise capacity (pVO2), compared to the placebo group. Camzyos continues to establish additional evidence for its long-term safety and efficacy. At the European Society of Cardiology annual congress (ESC 2024) in September, results from the MAVA-LTE clinical study evaluating Camzyos' long-term effects and safety were unveiled. Interim results showed that at week 180 of treatment, 66.3% of patients achieved NYHA Class I, with 46.8% demonstrating a complete response (NYHA Class I+Valsalva LVOT pressure gradient of ≤30 mmHg). The NYHA classification system, established by the New York Heart Association, evaluates the extent of symptoms and activity limitations in patients. Additionally, N-terminal pro-brain natriuretic peptide (NT-proBNP) levels decreased by 81% from baseline at week 180, with 53.8% of patients reaching normal NT-proBNP levels. NT-proBNP serves as a biomarker for assessing heart failure severity and prognosis, often elevated under conditions of excessive myocardial stress or stretch in heart failure patients. The EQ-5D-5L score, which assesses health-related quality of life, showed improvement, indicating better subjective health perceptions among patients. "Camzyos' long-term data, confirmed through the MAVA-LTE study, shows the positive potential of the drug. Patients' symptoms have been consistently maintained well during 3 years of long-term study, and the safety profile has also been consistent," Dr. Lakdawala emphasized. "In fact, the number of patients choosing to undergo surgical treatments is declining after the introduction of Camzyos. The Real-World Data of Camzyos confirmed in clinical practices show an equivalent level of effectiveness and safety profile to results demonstrated in previous clinical studies," Dr. Lakdawala added. "Although the outcomes may vary depending on individual's pathophysiology, most patients undergone Camzyos treatments also have significantly improved symptoms or show much improved responses." "Camzyos' myocardial remodeling effect, which improves cardiac function and structure, has gained most attention since the early EXPLORER-HCM study," Dr. Lakdawala stated. "The study results showed significant reductions in key indicators of cardiac hypertrophy in HCM, such as left ventricular wall thickness and left ventricular mass, following Camzyos treatment. These changes were observed as early as 24 to 30 weeks into the treatment and were sustained over the long-term treatment period," he added. Despite the introduction of targeted treatment option..undiagnozed patients↑ Despite the recent introduction of targeted treatment option, diagnosing oHCM is still challenging. According to Dr. Lakdawala, many cardiomyopathy patients often adapt to their long-standing symptoms, and they fail to recognize their condition. Typically, as symptoms gradually restrict physical activity, patients adjust to a limited lifestyle and forget that their health status is not normal. Dr. Lakdawala explained that many patients only realize that HCM caused their past symptoms after receiving a diagnosis and experiencing improvement following treatment. "The issue of undiagnosed HCM is one of the major global challenges today. To address this issue, it is crucial to educate cardiology healthcare providers through multiple channels to help them understand that patients’ symptoms may be associated with this condition," Dr. Lakdawala emphasized. "When there is a thickening of the left ventricular wall, it is important not to simply attribute it to secondary effects of hypertension or overlook the severity of the condition. Additionally, the lack of appropriate imaging diagnostics, which often leads to missed diagnoses of HCM, is another critical issue that must be resolved," he stressed. With the introduction of Camzyos, patients' left ventricular outflow obstruction and related symptoms can be improved by taking an oral drug once a day. While surgical treatment is still necessary for some patients, most are expressing satisfaction that their symptoms can be effectively managed through oral medication alone, according to Dr. Lakdawala. "Recent guidelines for HCM in the United States and Europe prioritize a patient-centered approach above all," he stated. "These guidelines focus on symptom management as the primary goal and emphasize expanding treatment options to improve symptoms. Previously, surgical treatments like septal reduction therapy (SRT) had been the primary option. Introducing Camzyos in the guidelines provided a new option, expanding patients' treatment choices." Dr. Lakdawala added, "In the past, HCM patients were often prohibited or restricted from engaging in physical activity. However, recent studies have confirmed that appropriate levels of exercise are safe for these patients. Based on this evidence, we are gradually relaxing guidelines to permit regular exercise and moderate physical activity, while continually seeking ways to enhance the quality of life for patients with HCM."
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- NeuroBiogen enters into Binding Term Sheet with US Company
- by Lee, Seok-Jun Dec 12, 2024 05:50am
- Scilex Holding Company, a Nasdaq-listed company, announced that d a binding Term Sheet had been signed between NeuroBiogen, a Korean company specializing in innovative new drugs, and Scilex Bio, a controlling interest of joint venture by Scilex Holding Company on December 10th, local time. Under the terms of the agreement, Scilex Bio will be granted an exclusive worldwide license to develop and commercialize tisolagiline (KDS2010), an oral treatment for Alzheimer's disease and obesity that is in clinical development by NeuroBiogen. The collaboration will leverage NeuroBiogen’s R&D capabilities for KDS2010 and Scilex’s commercialization expertise in the central nervous system and first-line therapy. “We are currently in the process of finalizing a term sheet with Scilex for the formal agreement, and are currently negotiating the details of the agreement,” said a NeuroBiogen representative. NeuroBiogen has successfully completed a Phase I clinical trial on KDS2010 for Alzheimer's disease and obesity and is conducting a Phase II trial. Meanwhile, Scilex, which was founded in 2011, is a leading research and development company for CNS-related therapies, including FDA-approved treatments for gout, migraine, and non-opioid painkillers.
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- 'Effective in Asian patients' Leclaza vs Tagrisso comb
- by Son, Hyung Min Dec 12, 2024 05:49am
- Leclaza plus Rybrevant and Tagrisso plus platinum-based chemotherapy have shown consistent effects in Asian patients. The effects of the combination therapy of Leclaza and Tagrisso, which are non-small cell lung cancer (NSCLC) treatments, have been unveiled at the European Society for Medical Oncology (ESMO) Asia Congress 2024. ESMO Asia Congress 2024 took place over three days, starting on December 6, in Singapore. The concurrent use of Leclaza with Rybrevant subcutaneous (SC) formulation showed non-inferior results compared to the conventional Rybrevant intravenous (IV) injection. Tagrisso plus platinum-based chemotherapy has consistently improved overall survival compared to Tagrisso monotherapy in Asian patients. Leclaza plus Rybrevant SC formulation, injection-related adverse reactions sixfold↓in the PALOMA-3 study Combination therapy of YuhanAccording to industry sources on December 10, Janssen unveiled the result of the PALOMA-3 clinical trial, which was to investigate the potential of Leclaza plus Rybrevant SC formulation, treatments for epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC). Previously, in this clinical study, Leclaza plus Rybrevant SC showed non-inferiority compared to Leclaza plus Rybrevant IV. Leclaza plus SC Rybrevant combination therapy had an objective response rate (ORR) of 30.1%, whereas Leclaza plus IV Rybrevant combination therapy had an ORR of 32.5%, meeting the non-inferiority requirement. Leclaza plus SC Rybrevant combination therapy showed a positive trend regarding progression-free survival (PFS). PFS refers to a duration during which a patient's disease does not worsen. Unlike the oral formulation of Leclaza, Rybrevant was developed as an IV injection. For Rybrevant IV inj, patients have the inconvenience of visiting the hospital once every 2-3 weeks, and the administration takes more than an hour. Janssen plans to develop an SC formulation to offer ease of administration and reduce concern regarding adverse reactions related to injection. SC formulation is expected to improve patient convenience since it can significantly reduce the administration duration to within 10 minutes. The latest presentation is a follow-up clinical result where the efficacy and safety of the drug were evaluated in 255 Asian patients out of the total 418 study participants. Patients had previous treatment history of receiving AstraZeneca's targeted therapy Tagrisso and platinum-based chemotherapy. During the first 4 months of the treatment, 74% of the Leclaza+Rybrevant SC group and 75% of the Leclaza+Rybrevant IV group received anticoagulant agents to prevent venous thromboembolism (VTE). The key endpoints included disease control rate (DCR), duration of response (DOR), PFS, overall survival (OS), and safety. Clinical results showed that the Leclaza+Rybrevant SC group had a DCR of 80.2%, and the Leclaza+Rybrevant IV group had a DCR of 72.9%. DCR refers to a percentage of delaying the disease progression to extend patient survival. For PFS, Leclaza+Rybrevant SC group showed a favorable trend. At 12 months, 77% of the patients treated with Leclaza+Rybrevant SC survived. It was 61% for those treated with Leclaza+Rybrevant IV. DOR and PFS could not be estimated. For injection-related response (IRR), the Leclaza+Rybrevant SC group had an IRR sixfold less than the Leclaza+Rybrevant IV group. Most responses were mild, Grade 1-2. For the VTE occurrence rate, 11% of the Leclaza+Rybrevant SC group treated with anticoagulant had VTE, and it was 12% for the Leclaza+Rybrevant IV group. It was 18% and 22% for those who did not receive anticoagulants, respectively. The safety profile of Asian patients corresponded to those in other countries. The effectiveness of Tagrisso+platinum-based chemotherapy as a first-line treatment has been reconfirmed AstraZenecaAstraZeneca unveiled the study results of the FLAURA2 cohort study, which involved Tagrisso+platinum-based chemotherapy in Asian patients. Previous results of this clinical study showed that Tagrisso+platinum-based chemotherapy demonstrates a statistically significant improvement in PFS compared to Tagrisso monotherapy. Patients had not previously received treatment, and they were randomly assigned 1:1 to Tagrisso plus pemetrexed (product name: Alimta) plus cisplatin/carboplatin group and Tagrisso monotherapy group. Participants were categorized into Chinese Asian/non-Chinese Asian/non-Asian. The primary endpoint included PFS, and the secondary endpoints included OS, ORR, DOR, and safety. The clinical results showed that the PFS of the Tagrisso combination therapy group was 25.5 months, which was over six months older than the 19.4 months in the Tagrisso monotherapy group. The median OS was 40.5 months for the Tagrisso combination therapy group and 38.3 months for the Tagrisso monotherapy group. The safety profile showed that the adverse event rates over Grade 3 in the Tagrisso combination therapy group were 67%, higher than in the Tagrisso monotherapy group. The adverse event rates due to discontinued use of Tagrisso were 10% for the Tagrisso combination group and 7% for the monotherapy group. "Tagrisso+platinum-based chemotherapy showed consistent benefits in Asian patients similar to the previous clinical results. Such clinical results demonstrate the potential of the therapy as a first-line treatment of Asian patients with EGFR-positive advanced NSCLC," a researcher remarked.
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- Merck Biopharma Korea and LG Chem will comarket Glucophage
- by Whang, byung-woo Dec 12, 2024 05:49am
- (from the left) In-Kyum Hwang, Head of the Diabetes and Cardiovascular Business Unit at Merck Biopharma Korea; In-Cheol Hwang, Senior Vice President of LG Chem’s Primary Care Business Division Merck Biopharma Korea announced on the 11th that it has signed a partnership agreement with LG Chem to jointly sell Glucophage (metformin hydrochloride), a treatment for type 2 diabetes, in Korea. Under the agreement, LG Chem will distribute Glucophage to healthcare providers in Korea starting January 1, 2025. Merck Biopharma Korea will continue to hold the marketing authorization. Glucophage is a treatment for type 2 diabetes, a condition in which the body becomes resistant to insulin, resulting in relatively impaired insulin secretion and elevated blood sugar. Since being first used in the clinic in 1957, it has been in use for more than 60 years and is recommended as a first-line treatment in the world's leading type 2 diabetes treatment guidelines, including the American Diabetes Association (ADA), the European Association for the Study of Diabetes (EASD) and the American Association of Clinical Endocrinology (AACE). The companies entered into the partnership agreement to expand their presence in the Korean diabetes market through the synergy of Merck's global quality management capabilities and LG Chem's strong marketing and sales capabilities. While LG Chem's Zemiglo product line holds a leading position in the domestic DPP-4 inhibitor market with a 23.8% share (according to UBIST, Q3 2024), the company's strategy is to further strengthen its presence in the diabetes treatment market through the sale of Glucophage. “Based on our close partnership with Merck, we will provide effective diabetes treatment solutions to our customers and further strengthen our market leadership position by continuously expanding our diabetes treatment portfolio,” said In-Cheol Hwang, Senior Vice President of LG Chem’s Primary Care Business Division. “Through our collaboration with LG Chem, we look forward to providing stable and reliable treatment options for diabetes patients in Korea,” said In-Kyum Hwang, Head of the Diabetes and Cardiovascular Business Unit at Merck Biopharma Korea. “Based on our corporate philosophy, ‘As One for Patients,’ we will continue to pursue patient-centric innovation and will continue our endeavors to improve the quality of life for people with type 2 diabetes.”
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- 'Lalaola' wins 2024 Pharma Industry ad grand prize
- by Son, Hyung Min Dec 11, 2024 05:54am
- The winner of the 2024 pharmaceutical and biotechnology industry advertising·PR awards has been announced. Yuhan's 'Lalaola' won the Grand Prize in the advertising category, and Amgen Korea's 'Blue Wish campaign' won the Grand Prize in the PR category. On December 10, Dailypharm (Publisher: Lee Jeong Seok) hosted the '2024 Korean Pharmaceutical & Biotech Industry Advertising·PR Awards Ceremony' at the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KBPMA)'s K-Room. This year, the awards ceremony marked 12 years, and 66 contents in the advertising and PR categories were submitted to compete. On December 10, Dailypharm (Publisher: Lee Jeong Seok) hosted the 12th The awards were categorized into the advertising and PR sectors. In the advertising category, a grand prize, three best prizes, and seven excellence awards have been selected. In the PR category a grand prize, two best prizes, and three excellence awards have been awarded. The awards were presented in the advertising category by the following sections: ▲TV·CF ▲Prints·Radio▲Internet·SNS, in the PR category: ▲Social Contribution·Disease Awareness Campaigns ▲Corporate·Product Promotion. Yuhan's 'Lalaola' won the Grand Prize in the advertising cateogry. The winner was presented with a plaque and a cash prize of KRW 5 million. Yuhan won the Grand Prize in the advertising category. The award recipient Kim Jong-won, Director of External Affairs at Yuhan, stated, "Lalaola was launched in South Korea in July 2023, and this year, we have made efforts to promote the product. We hope Lalaola will grow in the market for high-dose arginine, similar to Mag-B. We look forward to participating in the ceremony next year again." In the TV·CF category, Johnson & Johnson Korea's 'Tylenol' and Iksu Pharmaceutical's 'Iksu Kongjin-dan' were awarded the best prize, receiving plaques and a cash prize of KRW 3 million. Handok's 'Ketotop,' Chong Kun Dang's 'Braining Cap,' Reckitt Korea's 'Gaviscon,' and Daewon Pharm's 'Coldaewon Kids' won the excellence awards. In the Internet·SNS category, Jeil Health Science's 'Jeil Cool Pap' was awarded the best price. Excellence awards were given to Dongkook Pharmaceutical's 'Cencia' and Kyung Nam Pharm's 'PM-Zol-Q series,' each receiving trophies and a cash prize of KRW 2 million. Dongsung Bio Pharm's 'Loxo-N Gel' won the excellence award in the Prints·Radio category. In the PR category, entries that delivered meaningful messages to society, particularly those focusing on social contributions and ESG activities, were awarded. This year's grand prize in the PR category went to Amgen Korea's 'Blue Wish campaign,' a social contribution initiative fulfilling the wishes of children with rare diseases. The award included a plaque and a cash prize of KRW 5 million. Seohyun Kim, Director of External Affairs at Amgen Korea, said, "We are pleased to receive such an honorable award. Three weeks ago, we decorated a room for a child who has been battling leukemia for a long time. The child's dream was to have a newly decorated room, and fulfilling that dream was deeply moving. I'll be joining the volunteers tonight, and I intend to dedicate this award to them. I will also donate the prize money." In the PR subcategory for Social Contribution·Disease Awareness Campaigns, the best awards went to Novartis Korea's 'Shine a Light on HS (Hidradenitis Suppurativa)' campaign. Sanofi's 'Helping Hands' campaign received the excellence award. In the Corporate·Product Promotion category, the best prize was awarded to HK Inno. N's corporate promotion program, which received a plaque and a cash prize of KRW 3 million. JW Pharmaceutical's 'JW R&D Insight' and Shinshin Pharmaceutical's 'Short Form' campaign won excellence awards. Korean Pharmaceutical & Biotech Industry Advertising·PR Awards were established in 2013 to encourage advertising and PR professionals who bring new value to the pharmaceutical industry and medicines and promote the creation of advertisements that resonate with pharmacists, the primary target of pharmaceutical advertising. In his opening remarks, In-ho Ga, Head of the Dailypharm's Press Department, stated, "I believe the fresh and creative ideas of advertising and PR professionals have made significant contributions to pharmaceutical branding. I sincerely congratulate the winning companies." This year's contest was judged by a panel led by Daechun Ahn, the former President of the Korean Advertising Society (Professor at Korea University), along with Jae Hoon Cheong, Professor at Sahmyook University College of Pharmacy, and Jae-Kook Lee, Senior Vice President of the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA). "We evaluated whether the strategy and messaging were clear and effectively conveyed in the advertising category. In the PR category, we focused on the campaigns' authenticity, consistency, and sustainability. Many excellent works that met the judging criteria were submitted," Ahn explained. "This event is meaningful in recognizing the hard work of advertising and PR professionals in the pharmaceutical and biotech industry over the past year. Next year, many PR professionals are expected to continue to play a pivotal role," Jae-Kook Lee, Senior Vice President of KPBMA remarked. Youngshin Lee, the CEO of the Korean Research-Based Pharma Industry Association (KRPIA), said in a video message, "The importance of precise pharmaceutical information has been emphasized, and the media environment is changing. Delivering accurate medication information is essential for helping patients and their families return to their daily routines. I extend my gratitude and encouragement to the advertising and PR professionals who design sincere campaigns to promote pharmaceuticals. I hope this advertising award acts as a meaningful platform that enhances the pride of PR professionals in the industry."
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- Lilly will directly distribute Trulicity in Korea next year
- by Lee, Tak-Sun Dec 11, 2024 05:54am
- Pic of Trulicity Lilly, who holds the marketing authorization for the diabetes drug ‘Trulicity (dulaglutide),’ which has been distributed by Boryung since 2016, will directly distribute the drug in Korea from next year. With the launch of the diabetes and obesity drug Mounjaro (tirzepatide) expected next year, it is expected that this change of distributors will have an impact. According to industry sources on the 9th, Lilly Korea told its customers that the distributor for Trulicity 0.75mg/0.5ml and 1.5mg/0.5ml disposable pens will be changed from Boryung to Lilly from next year. Boryung and Lilly signed a joint sales agreement in June 2016 to market and sell Trulicity in Korea. Under the agreement, Boryung has been the exclusive distributor of Trulicity in Korea. Trulicity is a GLP-1 receptor antagonist class diabetes drug. GLP-1 analogs are developed using the hormone glucagon-like peptide-1 (GLP-1), which is involved in the regulation of blood sugar in the body. GLP-1 analogs stimulate insulin secretion but are less likely to cause hypoglycemia, therefore has the advantage of lowering the risk of hypoglycemia compared to conventional insulin. It is also used to treat obesity because it suppresses appetite and supports weight loss. In particular, Trulicity has almost monopolized the domestic GLP-1 analog diabetes treatment market with its convenience of once-weekly administration to control blood sugar. Based on IQVIA, domestic sales were KRW 41.8 billion in 2020, KRW 49.9 billion in 2021, KRW 59.5 billion in 2022, and KRW 54.5 billion in 2023. However, the drug has been struggling with domestic supply due to increasing global demand. With Trulicity’s distributor changing from Boryung to Lilly, attention is also focused on the domestic supply of Mounjaro, which is expected to become the next-generation GLP-1 product. In addition to diabetes, Mounjaro gained an indication for obesity last year and has been regarded as a viable rival to Wegovy (semaglutide, Novo Nordisk). Given Lilly's relationship with Boryung, which had been tied by Trulicy, many in the industry had expected Boryung to distribute Mounjaro. However, with Lilly taking over direct distribution from next year, it is expected that Mounjaro will be supplied by Lilly itself or a third domestic pharmaceutical company. An industry insider explained, “It is difficult to predict a drug’s copromotors because there are many interested parties involved. The company said it will distribute Trulicity directly next year, but we don't know how the situation will change.”
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- Jemperli expands indication to all endometrial cancers
- by Whang, byung-woo Dec 11, 2024 05:52am
- Jemperli's (dostarlimab) indication was expanded to include its use as a first-line treatment in combination with platinum-based chemotherapy for all patients with advanced or recurrent endometrial cancer. The drug is expected to further expand its influence, with the Health Insurance Review and Assessment Service's Cancer Disease Deliberation Committee passing the drug’s use as first-line treatment of advanced or recurrent dMMR/MSI-H endometrial cancer in combination with platinum-based chemotherapy in October. Pic of Jemperli On the 10th, GSK Korea announced that it had received approval from the Ministry of Food and Drug Safety (MFDS) to expand Jemperli’s indication to include all patients with advanced or recurrent endometrial cancer on the 9th. This indication expansion allows Jemperli to be used as a first-line treatment for all patients with advanced or recurrent endometrial cancer, regardless of whether they have a mismatch repair defect (dMMR)/high-frequency microsomal instability (MSI-H). The Phase III RUBY study, which became the basis of Jemperli’s approval, evaluated Jemperli in combination with platinum-based chemotherapy (carboplatin plus paclitaxel) versus placebo and platinum-based chemotherapy in 494 patients with advanced or recurrent endometrial cancer. The study was designed to include at least 3 years of treatment given that the median survival for conventional platinum-based chemotherapy is less than 3 years. The primary endpoints were progression-free survival (PFS) and overall survival (OS) according to Response Evaluation Criteria in Solid Tumors (RECIST). Study results showed that the Jemperli combination arm reduced the risk of death by 31% compared to the control arm in patients with advanced or recurrent endometrial cancer. Over a median follow-up of 37 months, the median overall survival (OS) of patients receiving the Jemperli combination was 44.6 months, 16.4 months longer than the control arm (28.2 months), and the risk of death was reduced by 31%. The safety profile was consistent with the last interim analysis, with no new safety information observed. The most common treatment-related adverse events were fatigue, hair loss, and nausea, most of which were mild to moderate. Jae Kwan Lee, Professor at Korea University Guro Hospital (President, Korean Society of Gynecologic Oncology), said, “Endometrial cancer is a disease that carries a high risk of recurrence even after initial treatment. This is why an effective first-line treatment option is critical for the patients. The RUBY study is regarded as an important study that demonstrated the long-term effectiveness of immune-oncology drugs in endometrial cancer.” Lee added, “Jemperli in combination with platinum-based chemotherapy is the only immuno-oncology agent available for the treatment of endometrial cancer in Korea that has been shown to improve OS. We look forward to seeing more patients benefit from the clinical value of Jemperli in the future, as we have shown significant clinical value even though the study included patients who relapsed 6 months after chemotherapy and patients with high-risk diseases such as carcinosarcoma.” As a humanized IgG4 monoclonal antibody, Jemperli is a programmed death receptor-1 inhibitor (PD-1 inhibitor) that shows sustained antitumor activity in dMMR/MSI-H carcinoma. It was approved by the Ministry of Food and Drug Safety in December 2022 for the treatment of adult patients with recurrent or advanced dMMR/MSI-H endometrial cancer who are on or have progressed after prior platinum-based systemic chemotherapy and is reimbursed by health insurance.
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- MM drug Revlimid continues to thrive after patent expiry
- by Eo, Yun-Ho Dec 11, 2024 05:52am
- Sales of the multiple myeloma drug Revlimid continue to thrive even after patent expiry in Korea. According to industry sources, Bristol Myers Squibb Korea’s Revlimid (lenalidomide) still boasts its originality with an 80% market share. As of Q3 2024 (IQVIA), Revelimid's sales were KRW 11.2 billion, significantly outpacing the sales of generics such as Lenaloma (KRW 800 million), Lenalid (KRW 981.1 million), Leblikin (KRW 305.85 million), and Lenaldo (KRW 35.51 million) during the same period. Revlimid has been used for various blood diseases for nearly 20 years since its approval by the U.S. Food and Drug Administration (FDA) in 2005 and has solidified its position as the “forefather” in the blood cancer treatment space. In particular, it has become the backbone in the multiple myeloma treatment space, being used in combination with newer therapies. Since its launch in 2009, it has been expanded to gain approval for 7 indications in four diseases, including multiple myeloma, and has been used in various combinations regardless of transplantation history or lines of treatment. In the recently updated National Comprehensive Cancer Network (NCCN) guidelines, combination therapies that include Revlimid are now recommended as Category 1 Preferred regimens, demonstrating the solid foundation it has built over the past 20 years. In clinical practice, Revlimid is actively used in combination with various therapies as a first-line treatment for multiple myeloma in Korea and abroad. Since April 2022, RVd therapy has been reimbursed by insurance in Korea, enabling newly diagnosed patients with multiple myeloma to receive REVLIMID regardless of whether or not they receive an autologous stem cell transplant. In addition to the first-line treatment, the relapsing nature of multiple myeloma makes it critical to maintain a favorable post-transplant prognosis with maintenance therapy, and starting in January 2023, Revlimid maintenance therapy was reimbursed and is available as a treatment option that focuses on improving survival in patients who achieve a stable disease response or better following autologous stem cell transplant. In a meta-analysis of three randomized controlled trials of Revlimid (CALGB 100104, IFM 2005-02, GIMEMA RV-MM-PI-209) conducted on 1,208 patients (605 in the lenalidomide maintenance arm and 603 in the placebo or observation arm), the PFS (progression-free survival) of patients that used Revlimid maintenance as monotherapy was 52.8 months, which was an over twofold improvement from the 23.5 months observed in the control arm, reducing the risk of relapse and death by 52%. At a median follow-up of 79.5 months, median overall survival (OS) in the Revlimid maintenance arm was not reached, compared to 86.0 months in the placebo or observation arm. At a median follow-up of 88.8 months, median overall survival (mOS) in the maintenance arm was 111 months, an increase of 25 months compared to 86.9 months in the placebo or observation arm, and the risk of death was significantly reduced by 23% compared to placebo or observation arm. Revlimid maintenance therapy is recommended at the highest level in both the NCCN and European Society for Medical Oncology (ESMO) guidelines. Hyeon Seok Eom, Professor of Hematology/Oncology at the National Cancer Center said, “Revlimid has been used for many years in multiple myeloma patients at various stages of treatment, from first-line to maintenance therapy,” said Dr. Hyunseok Eom, Professor of Hematology/Oncology at the National Cancer Center. As it has consistently provided multiple treatment options for patients with multiple myeloma in Korea and abroad, we expect it to bring positive synergies with the new drugs under development.”
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- Antibiotic clarithromycin market grows fourfold in 3 yrs
- by Chon, Seung-Hyun Dec 10, 2024 05:53am
- The prescription market for the antibiotic clarithromycin has significantly expanded. The market size grew by nearly fourfold over three years. Impurities-related cautions were once issued, but the volume of use increased during the COVID-19 pandemic and endemic period. According to a pharmaceutical market research firm UBIST on December 9, the outpatient prescription market for clarithromycin in Q3 amounted to KRW 35.6 billion, up 45.6%. The macrolide antibiotic clarithromycin is a medicine used to treat respiratory infections, pneumonia, pharyngitis, tonsillitis, and sinusitis. Quarterly outpatient prescription sales for clarithromycin (unit: KRW 100 million, source: UBIST). The prescription market for clarithromycin has significantly increased throughout the pandemic and endemic period. In Q3 2021, prescription sales of clarithromycin amounted to KRW 9.3 billion, which was nearly a four-fold expansion in three years. During the early spreading of COVID-19, strengthened individual hygiene behaviors, such as washing hands and wearing masks, decreased patients with infectious diseases such as flu and the common cold. The market for clarithromycin also shrunk significantly. In Q3 2019, the prescription market size for clarithromycin amounted to KRW 14.7 billion. However, it shrunk by 36.9% in two years. As patients tested positive for COVID-19 rapidly increased since the end of 2021, the prescription market for clarithromycin entered a boom cycle. Analysis suggests that the market for clarithromycin grew more even after the end of the pandemic due to increases in patients with flu or the common cold. The prescription market size for clarithromycin in Q3 was recorded as second in history following Q4 last year. Even after the past issue of impurities, prescription demands for clarithromycin increased significantly. In September 2022, the Ministry of Food and Drug Safety (MFDS) issued pharmaceutical companies with the mandate to check the N-Nitrosodimethylamined (NDMA) contents of pharmaceuticals containing the active ingredient clarithromycin. The MFDS has ordered pharmaceutical companies to submit test results for representative batches of finished products containing clarithromycin that are available on the market. This action follows reports of NMDS exceeding acceptable limits in clarithromycin tablets overseas, which led to product recalls. The MFDS requested companies to submit the results immediately once the testing is completed, even before the deadline for the impurities document submission. After that, voluntary returns of clarithromycin-containing medicines as a precautionary measure were taken. The market for clarithromycin recorded KRW 46.5 billion in 2022. Last year, it grew to KRW 120.2 billion, exceeding KRW 100 billion for the first time in history. As mycoplasma infections quickly spread in China last year, concerns about clarithromycin production have risen in South Korea. At the end of last year, the MFDS visited manufacturing plants of pharmaceutical companies and monitored supplies and production·amount of shipment of active ingredients, such as clarithromycin and azithromycin, used for treating mycoplasma pneumonia infections.
