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- 2026-06-25 07:30:13
- Policy
- New drugs Zeposia, Koselugo, Trimbow are reimbursed
- by Lee, Tak-Sun Dec 19, 2023 05:53am
- New ulcerative colitis drug .that will be reimbursed from next year New drugs including Zeposia Cap, Koselugo Cap, and Trimbow Cap will be listed for reimbursement starting January next year. In addition, Dong-A ST's diabetes combination drug ‘Sugatree XR Tab’ will also be reimbursed, and the reimbursement standards for drugs that have undergone reevaluation of their reimbursement adequacy will be adjusted as well. On the 18th, the Ministry of Health and Welfare announced that it has issued an administrative notice of the 'Partial Amendment of Details on the Application Standards and Methods of Medical Benefits' that contain the matters above, for enforcement as of January 1 next year. Zeposia Cap is used to treat moderate-to-severe active ulcerative colitis in patients who respond adequately to existing treatment or biological agents including corticosteroids, 6-Mercaptopurine, or azathioprine, or have no response, or have no resistance and are contraindicated to use such drugs. Trimbow Inhaler is used in adults (over 18 years of age) to treat moderate-to-severe chronic obstructive pulmonary disease (COPD) and asthma. In COPD, Trimbow is used for maintenance treatment in patients whose disease is not adequately controlled despite treatment with a combination of two medicines consisting of a long-acting beta-2 agonist plus either an inhaled corticosteroid or a long-acting muscarinic receptor antagonist. In asthma, Trimbow is used for maintenance treatment in adults whose disease is not adequately controlled despite treatment with a long-acting beta-2 agonist plus a medium or high dose of inhaled corticosteroid, and who had one or more exacerbations within 12 months. Koselugo is used conditionally for the treatment of pediatric patients over 3 years but 18 or below with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). The patient’s PN is regarded inoperable if the lesion cannot be surgically completely removed without risk for substantial morbidity due to: encasement of or close proximity to vital structures, invasiveness, or high vascularity of the PN. Dong-A ST’s triple antidiabetic combination ‘Sugatree XR Tab’ will also be listed for reimbursement. The drug is a combination of metformin hydrochloride, dapagliflozin, and evogliptin. The MOHW added Sugatree’s combination to the list of dapagliflozin+sitagliptin+metformin combinations that were previously granted reimbursement as part of a metformin+SGLT2i+DPP4i regimen since April this year. Meanwhile, the reimbursement standards for drugs that have undergone reevaluation of their reimbursement adequacy in 2023 will also be adjusted at the same time. The results of the subject substances were presented at the Health Insurance Review and Assessment Service's Drug Benefits Evaluation Committee in July. The drugs for which reimbursement standards will be revised are loxoprofen sodium, limaprost alfadex, and epinastine hydrochloride. Loxoprofen’s antipyretic and analgesic indications for acute upper respiratory tract infections and limaprost alfadex’s indication for the treatment of ischemic symptoms of Buerger's disease will be removed from the reimbursement standards. In addition, the use of epinastine hydrochloride for bronchial asthma will be removed from the reimbursement list. Meanwhile, HA eye drops, which the government decided to continue discussions on its reevaluation results, will not be included in the upcoming reimbursement standard revisions.
- Company
- Who will take over the Forxiga market worth 50 bil?
- by Chon, Seung-Hyun Dec 18, 2023 05:31am
- The pharmaceutical industry is closely monitoring the potential withdrawal of the diabetes drug Forxiga from the market in Korea. This withdrawal is expected to intensify competition among companies aiming to fill the market gap left by Forxiga. Companies that have recently introduced generics of Forxiga are predicted to enter intense market competition. Furthermore, there is speculation that Daewoong Pharmaceutical, having launched a new medication from the same class this year, could benefit from these developments. According to the industry, AstraZeneca Korea has officially declared on the 14th its exit from the Korean market with its diabetes treatment Forxiga. This decision by AstraZeneca to withdraw from the market is attributed to increased competition arising from the introduction of generics, drug price cuts, and restructuring of their portfolio. Forxiga is a SGLT-2 inhibitor class treatment for diabetes and contains dapagliflozin as its active ingredient. SGLT-2 inhibitors function by preventing the reabsorption of glucose in the kidneys, which leads to the excretion of glucose via urine and consequently lowers blood sugar levels. According to the data from UBIST, a market research firm, Forxiga’s prescription totaled to 51 billion won in the previous year. Therefore, pharmaceutical companies already in the SGLT-2 inhibitor market may likely benefit from the Forxiga's withdrawal. SGLT-2 inhibitors, which are used as diabetes treatments, has recently shown rapid growth in sales. In Q3 of this year, SGLT-2 inhibitors monotherapy achieved outpatient prescription sales of 37.7 billion won. This reflects a 41.0% increase compared to the previous year. From Q3 of 2020, where it reached 20.1 billion won in sales, there has been a remarkable 87.2% growth over three years. SGLT-2 inhibitors, unlike DPP-4 inhibitors which are another class of diabetes treatments, offer an insulin-independent mechanism of action; therefore, they are not affected by insulin resistance. Additionally, clinical studies that demonstrate benefits in weight loss are seen as a positive factor contributing to the market expansion of SGLT-2 inhibitors. The recent sales for dapagliflozin monotherapy, including Forxiga, have shown a steep increase in growth. Q3’s prescription sales of dapagliflozin monotherapy reached 20.5 billion won, up 56.0% YoY compared to the last year. The market size has approximately doubled from the 10.9 billion won in Q3 of 2021, demonstrating substantial expansion over just two years. The market has significantly expanded recently with the introduction of Forxiga generics. Following the expiration of Forxiga's substance patent in April, numerous pharmaceutical companies in Korea rushed to release generics containing the dapagliflozin. Currently, there are approximately 60 companies that have introduced generics of Forxiga monotherapy. Dapagliflozin’s prescription sales was recorded at 14.5 billion won in Q1, and it increased to 17.9 billion won in Q2, up 23.4%. Compared to Q1, the prescription sales in Q3 increased by 40.8%. For pharmaceutical companies, Forxiga's market exit is seen as an opportunity to grow through the substitution of generics that contain the same active ingredient. In the early stage of the Forxiga generic market, Boryung Pharmaceutical and Hanmi Pharmaceutical are emerging as key players. Boryung's Trudapa has achieved prescription sales of 1.2 billion won since its introduction, while Hanmi's Daparon has recorded a prescription amount of 1.1 billion won in the past six months. Additionally, other companies like Chong Kun Dang, Aju Pharm, KyugDong Pharmaceutical, and Daewon Pharmaceutical have also seen prescription figures exceeding 500 million won. Following Forxiga's withdrawal, prescriptions of other for-2 inhibitors like empagliflozin, ipragliflozin, ertugliflozin, and enavogliflozin may also rise. Empagliflozin, already a significant player in the SGLT-2 inhibitor market alongside dapagliflozin, is expected to potentially benefit from this market shift. Empagliflozin monotherapy’s sales from prescription reached 14.6 billion won in the Q3, a YoY 53.0% increase from 9.5 billion won in the Q3 of 2020, demonstrating a strong growth. As for Empagliflozin-class monotherapy, Boehringer Ingelheim's Jardiance is currently the only product. Daewoong Pharmaceutical's new drug Envlo may rise to become a viable competitor in the SGLT-2 inhibitor market. Envlo, which contains the active ingredient Enavogliflozin, is Daewoong Pharmaceutical’s SGLT-2 class inhibitor, which was developed for the first time among domestic pharmaceutical companies. It received domestic approval last year and was launched in May. Envlo demonstrated superior efficacy with just 0.3 mg, which is less than one-thirtieth of the dose required by existing SGLT-2 inhibitors. In phase 3 clinical trials involving patients with type 2 diabetes, it proved superior in lowering glycated hemoglobin (HbA1c) and fasting blood sugar levels, as well as in safety, compared to existing drugs. Since its introduction, Envlo has achieved a prescription sales of 1.6 billion won. In Q2, it reached 400 million won in prescriptions, which then increased to 1.1 billion won in Q3. Despite being relatively new to the market and thus having a smaller prescription volume, Envlo has already outperformed the sales performance of ipragliflozin and etugliflozin, making it the third most prescribed drug in its class. In this sense, Envlo is beginning to establish a significant presence in the market, outshining Forxiga's generics. Daewoong Pharmaceutical’s past experience in marketing is postulated for the background of Envlo's market expansion. Since 2018, Daewoong Pharmaceutical has been a co-distributer of Forxiga, and had led its market expansion. Daewoong Pharmaceutical has proven its sales power in the anti-ulcer drug market. The company distributed AstraZeneca's PPI class anti-ulcer drug Nexium for 13 years, from 2008 to last year. This year, they have focused on selling self-developed gastroesophageal reflux disease drug, Fexuclue. Fexuclue has successfully penetrated the market, recording a prescription amount of 37.4 billion won in its second year until the Q3 of this year. Last year, Daewoong Pharmaceutical launched Nexierd, containing the active ingredient Esomeprazole, and its cumulative prescription sales in Q3 of this year reached 4.8 billion won, ranking it among the top in its class. AstraZeneca has secured the domestic supply of Forxiga until the first half of next year and is discussing patient protection measures with the Ministry of Food and Drug Safety (MFDS).
- Company
- Dupixent seeks to expand its indication to COPD
- by Eo, Yun-Ho Dec 18, 2023 05:31am
- Indications for the interleukin inhibitor ‘Dupixent’ is being expanded actively in the field. According to industry sources, after being approved for rashes, Sanofi’s Dupixent (dupilumab) has further demonstrated efficacy in chronic obstructive pulmonary disease (COPD) and is seeking to expand its indication to the area. Its indication for itchy rashes has been approved recently in Korea. Specifically, it has been approved for the treatment of adult patients aged 18 years or older with moderate-to-severe prurigo nodularis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Prurigo nodularis is a chronic, debilitating inflammatory disease that is correlated with the skin, immune system, and nervous system in association with type 2 inflammation. The intense itching arising from the condition can be worsen continuously due to neuro-immune interactions. It can occur at any age but has a particularly high incidence in people in their 50s and 60s. More than 80% of patients experience itching lasting more than 6 months and more than 50% experience itching lasting more than 2 years. Over 60% experience sleep disturbances and affected patients were found to be more likely to suffer from depression and anxiety than healthy individuals. Dupixent is a fully human monoclonal antibody that inhibits the signaling pathways of interleukin-4 (IL-4) and interleukin-13 (IL-13), which are the main causes of Type 2 inflammation. IL-3 and IL-13 are known to be key and central drivers of the type 2 inflammation that plays a major role in multiple diseases including prurigo nodularis, atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), etc. The indication expansion to prurigo nodularis was made based on the data from two placebo-controlled Phase III trials, PRIME and PRIME2. Pruritus improvement in the two trials, as measured by the proportion of patients with a ≥4-point reduction in Worst Itch Numeric Rating Scale (WI-NRS), showed that 60% and 57.7% of patients in the Dupixent arm of the PRIME and PRIME2 study achieved significant WI-NRS reduction, compared with the 18.4% and 19.5% in the placebo arm, respectively. In terms of treatment effect on skin lesions, 48% and 45% of patients in the Dupixent arm of the PRIME and PRIME2 trial continued to show improvement at Week 24, achieving more than double reduction of ‘clear’ or ‘almost clear’ skin. Expectations for the drug’s potential in COPD had risen with the company’s announcement of positive results from its second Phase III trial, NOTUS. The NOTUS is a placebo-controlled Phase III trial that evaluated the efficacy and safety of Dupixent in adults whose conditions are not controlled using triple therapy of inhaled corticosteroids (ICS), long-acting beta-agonists (LABA), and long-acting muscarinic antagonists (LAMA). The study found that Dupixent rapidly and significantly improved lung function by week 12 and that these benefits were sustained through week 52. Based on the positive results of the landmark BOREAS study the FDA granted Breakthrough Therapy designation for Dupixent as an add-on maintenance treatment in adult patients with uncontrolled COPD associated with a history of exacerbations and an eosinophilic phenotype
- Policy
- PVA price cut rate will be raised by up to 15%
- by Lee, Tak-Sun Dec 18, 2023 05:31am
- From next year, items with higher insurance claims will be subject to higher price cuts when negotiating prices through the Price-Volume Agreement (PVA) system. The maximum price cut rate is also expected to be raised to 15% from the current 10%. However, the exclusion limit will also be raised to KRW 3 billion from the current 2 billion won, which is expected to increase the range of small and medium-sized products that benefit. The National Health Insurance Service reportedly held a public-private consultative body meeting with the Korea Pharmaceutical and Bio-Pharma Manufacturers Association and shared the plans above on the 15th. With this public-private consultation meeting as its last, the NHIS will prepare a final draft with the Ministry of Health and Welfare and apply the changes from January next year. However, changes requiring revision of notifications will be implemented after April next year. A change that does not require revision of the notification – changing the formula to be applied differently according to the claims amount – will be implemented from January next year. Based on the threshold of KRW 30 billion, a higher reduction rate will be applied for higher claims amounts. However, the range of items that are exempt from being applied PVA will be expanded. Currently, drugs with insurance claims of less than KRW 2 billion are excluded, but the plan is to raise this criterion to KRW 3 billion. In addition, a measure has been put in place to adjust the reduction rate or provide refunds for items with temporarily increased usage due to infectious disease situations or unstable drug supply, such as in the case of respiratory drugs that were sued for COVID-19. Furthermore, the innovative drugs mentioned will be recognized for their fair value, and the reduction rate will be lowered for innovative new drugs. If an innovative drug is subject to negotiation 3 times in 5 years, the discount rate will be reduced further during the third negotiation. The maximum reduction rate will be raised from the current 10% to 15-20%, with 15% being the most likely rate considering the range deemed acceptable by the pharmaceutical industry. The rate is expected to be implemented after April next year as it requires revision of the notification. The PVA improvement plan has been discussed with the pharmaceutical industry through a public-private consultative body after the results of the ‘A study on the performance of the Price-Volume Agreement System and measures on its improvement’ that Professor SeungJin Bae from Ewha Womans University's College of Pharmacy participated as the principal investigator, was released in April. The contents shared during the final public-private consultative body meeting were also based on the results of the research service. However, the final draft excluded the research service’s proposal of adding items whose claims had increased by 10% and exceeded by over KRW 5 billion in Type A of the PVA system, which the pharmaceutical industry responded most sensitively to.
- Opinion
- [Reporter’s view] On improving self-sufficiency of APIs
- by Kim, Jin-Gu Dec 18, 2023 05:31am
- The government said it has planned to lower reliance on imports of cutting-edge parts and raw materials from foreign countries to below 50%. The Ministry of Trade, Industry, and Energy (MOTIE) recently announced a ‘3050 strategy for the industry supply chain,’ which aims to lower the reliance on imports from any single foreign country for 185 key categories that are utilized in semi-conductor, secondary battery, and automobiles to below 50% by 2030. This strategy is intended to eradicate the root of the problem amid recent concerns about the ‘shortage of urea solution.’ In the bio-category, items such as biological media, biomedicines, and disposable bags were included. However, active pharmaceutical ingredients were not included in this category because the selected items for the bio-category were mainly materials, parts, and equipment. However, the pharmaceutical industry is pointing out that the rationale behind the current policy is closely related to the domestic API situation in Korea. The problem is that Korea’s reliance on foreign raw materials is extremely high, particularly from a single country such as China. This situation is the same for APIs. Korea’s self-sufficiency rate of APIs is low, with growing reliance on imports from China. In fact, according to the Ministry of Food and Drug Safety (MFDS), Korea's self-sufficiency rate for APIs had been merely 24.4% in2021. Since 2008, Korea's self-sufficiency rate remains at 20% on average. By country, Korea has improted the most from China, worth a total of $740.23 million (approximately 950 billion won) in 2021 alone. This amount is over three times higher than the imports made from the second-highest country, India, which totaled at $225.35 million. Similar to the urea situation, if the supply of APIs from China to Korea is blocked somehow, it would well hinder the production and supply of the finished drugs as well. Depending on circumstances, this could worsen the issues like the repeated shortage of acetaminophen-based cold medicines that arose this year. However, despite the suggestions that have been made on the necessity to increase the self-sufficiency of domestic raw material drugs, no specific aim has been set to resolve the self-sufficiency issue. Additionally, there is a lack of social consensus on the level of self-sufficiency that would be deemed adequate. Specifically, discussions on which and how much API should be produced is needed. Currently, only statistics regarding the domestic production volume and the amount and country of origin for imported rAPIS are available. Statistics on which APIs are being produced domestically and which are imported from foreign countries are not available. Due to the current circumstances, Korea's response has been limited to implementing countermeasures, like assigning a task force if any issues emerge. There are systems in place that designate drugs as national essential medicines or shortage prevention drugs; however, these systems pertain to finished drugs, so it does not directly address the self-sufficiency rate of APIs. Although there are calls to increase the self-sufficiency rate of raw material drugs, no substantial progress has been made for its implementation. Therefore, a policy with a clear goal needs to be set by identifying specific APIs that need domestic production, understanding the level of reliance on foreign sources for these materials, and evaluating the practicality of achieving domestic self-sufficiency, among others. A potential strategy could be for the Ministry of Health and Welfare (MOHW) to lead the process by designating essential APIs, akin to how the MOTIE designated 185 key industrial materials. Furthermore, pharmaceutical companies should receive incentives for utilizing domestic APIs over cheaper alternatives from China. Additionally, when domestic APIs used, the companies should be eligible for broader preferential drug pricing and extended duration than existing standards.
- Reimb discussion on Braftovi and Luxturna continue next year
- by Eo, Yun-Ho Dec 18, 2023 05:31am
- Braftovi and Luxturna Industry attention is focused on the fate of the two new drugs that were unable to pass the final stage to reimbursement in Korea. According to industry sources, Ono Pharma Korea’s colorectal cancer drug Braftovi (encorafenib) and Novartis' retinal disease drug Luxterna (voretigene neparvovec-rzyl) have entered into extended negotiations with the National Health Insurance Service after failing to reach an agreement on their drug prices by the deadline. As a result, the two drugs will remain non-reimbursed until next year, unable not to be reimbursed in January 2024. The extended negotiations are likely due to delays in the companies’ headquarters approval of the final drug prices. In other words, there remains a gap between the two sides (government and pharmaceutical company) on the drug price. Braftovi passed the Cancer Disease Deliberation Committee review in January 2022, but it was not until August of this year, more than a year and a half later, that the Drug Reimbursement Review Committee deemed the drug adequate for reimbursement. After passing DREC review in August, it took more time for the company to accept the results and begin negotiations, and the NHIS and the company began pricing negotiations in earnest in October, which were eventually extended further to exceed this year. In the case of Luxturna, the drug passed DREC review in early September, and the company submitted its application for reimbursement benefits in September 2021 but made little progress after then. Although the drug was presented for deliberation to DREC in March, it failed to set reimbursement standards then, and after supplementing the data and reapplying for reimbursement, it was finally able to start pricing negotiations in October. There were reportedly disagreements over the terms of the Risk Sharing Agreement (RSA), including the refund rate, which may have played a role in stalling negotiations. As a result, it remains to be seen whether the two new drugs will be able to make it onto the reimbursement list in the first half of next year. Braftovi is an anticancer drug used for metastatic colorectal cancer with a confirmed BRAF V600E mutation. It is used in combination with Erbitux (cetuximab). In the Phase III BEACON CRC trial, the Braftovi+cetuximab combination demonstrated a statistically significant overall survival (OS) improvement to the irinotecan+ cetuximab combination. It is the only agent recommended as a first-line treatment for BRAF V600E-mutated colorectal cancer in leading global guidelines. Luxtruna replaces the defective or defective RPE65 gene - one of the causes of IRD - with a normal gene and restores the visual function of an IRD patient with a single administration. In other words, the drug provides a fundamental cure for IRD. In the US, the drug was granted a Breakthrough Therapy Designation by the FDA in 2014, and the drug was approved as an orphan drug in 2016, then was granted Priority Review and a Fast-Track designation in 2017.
- Company
- SK pneumococcal conjugate vaccine nears global entry
- by Chon, Seung-Hyun Dec 15, 2023 05:51am
- SK Bioscience is fast-tracking its global market strategy for its next-generation pneumococcal vaccine. Nine years following the start of their joint development with Sanofi, the company has now progressed to the last phase of clinical trials for commercialization. SK Bioscience has also been improving its vaccine production facilities to prepare for the commercial manufacturing of pneumococcal vaccines. SK Boscience announced on 11th that SK Bioscience and Sanofi have submitted a Phase 3 Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA) for its jointly developed 21-valent pneumococcal conjugate vaccine candidate, GBP410 (Sanofi’s project name: SP0202). SK Bioscience and Sanofi aim to enroll infants from various nations including the US, Europe, and Korea and complete Phase III clinical trials by 2027. In March 2014, SK Bioscience signed an agreement with Sanofi to jointly develop and commercialize an next-generation pneumococcal vaccine. The companies have rogressed to the last phase of clinical studies for the vaccine’s commercialization, nine years after signing the joint development agreement. GBP410 is a protein conjugate vaccine that combines specific proteins with the polysaccharide capsule of Streptococcus pneumoniae, which causes pneumonia and invasive pneumococcal disease. The conjugate vaccines are well known to provide superior protection among pneumococcal vaccines developed to date. GBP410s anticipated to offer broader protection over existing pneumococcal vaccines, given that it includes 21 serotypes. Serotypes are one of the key pathogenic factors in pneumococcal bacteria, and different serotypes are associated with varying pathogenicity. The newly introduced pneumococcal vaccine in Korea helps protect against 15 serotypes. SK Bioscience and Sanofi are preparing to commence the Phase 3 clinical study based on the successful completion of their Phase 2 clinical study of GBP410, The Phase 2 study by SK Bioscience and Sanofi was commenced in May 2020, enrolling 140 toddlers aged 12 to 15 months and 712 infants aged 42 to 89days from the US, Canada, and Honduras. GBP410 and a comparator vaccine were given to the cohorts as primary vaccination (2·4·6 months of age) and then as a booster vaccination (12-15 months of age). The results demonstrated comparable immunogenicity of GBP410 compared to the comparator vaccine. In terms of safety, no serious vaccine-related adverse reactions were reported in the GBP410-vaccinated group. GBP410 demonstrated equivalent immunogenicity and safety compared to the comparator vaccine when co-administered with recommended vaccines for infants and children, such as those for tetanus, diphtheria, pertussis, polio, and Haemophilus influenzae type B. SK Bioscience SK Bioscience has also started securing production facilities for GBP410. Last month, the company's board of directors agreed to invest approximately 81.5 billion won to expand their Andong L House vaccine production facility. This expansion, supported by a joint-investment with Sanofi, will lead to the construction of a roughly 45,208 square feet production facility. Once the FDA approves GBP410, SK Bioscience aims to manufacture the vaccine at Andong L House and distribute it to the global market . Once the commercialization of GBP410 is finalized, SK Bioscience plans to also launch the vaccine in Korea. Previously, SK Bioscience suffered defeat in the pneumococcal vaccine market in Korea. In 2016, SK Bioscience gained approval from the Ministry of Food and Drug Safety (MFDS) to market its pneumococcal vaccine, SKYPneumo Prefilled Syringe. SKYPneumo Prefilled Syringe is SK Bioscience's first premium vaccine. The company is positioning premium, next-generation vaccines as a pivotal element in its growth strategy. To achieve this, SK Bioscience has invested approximately 400 billion won in enhancing vaccine business infrastructure and R&D efforts. A significant step in this direction was the completion of the L House in Gyeongbuk Andong, in 2012. This facility stands as the largest vaccine factory in Korea, with an investment of about 200 billion won solely for its construction. After losing a patent lawsuit against Pfizer, SK Bioscience failed to launch SKYPneumo Prefilled Syringe. SK Bioscience had contested the validity of Pfizer's patent for PREVENAR 13 Inj by filing a lawsuit. In December 2018, the Supreme Court rejected the suit. Consequently, SKYPneumo Prefilled Syringe cannot be marketed until the Prevnar 13's patent expires in 2026. In response, SK Bioscience voluntarily withdrew the license for SKYPneumo Prefilled Syringe in 2020 but reacquired it the following year. “We are getting closer to successfully developing the pneumococcal conjugate vaccine that only few of the world’s top vaccine companies have succeeded in,” said Ahn Jaeyong, CEO of SK Bioscience. With 740,000 infants, children, and adolescents dying from pneumonia every year, we seek to contribute to global public health and rise to become a market-leading company by successfully developing GVP410."
- Policy
- Global orphan drug Lamzede receives GIFT designation
- by Lee, Hye-Kyung Dec 15, 2023 05:51am
- 'Lamzede Inj (velmanase)’ received the Global Innovative Products on Fast Track (GIFT) designation and will receive an expedited review in Korea. Lamzede is an orphan drug for which Kwang Dong Pharmaceutical signed an exclusive sales and distribution agreement with Italy's Chiesi Farmaceutical in July this year. As the GIFT program seeks to shorten the review period by at least 25%, the drug could be granted within 90 working days if Kwang Dong Pharmaceutical thoroughly submits the required supplementary materials. The Ministry of Food and Drug Safety recently announced that it had designated Lamzede, an enzyme replacement therapy for the treatment of non-neurological manifestations in patients with mild to moderate alpha-mannosidosis (AM) to receive review through the GIFT program. The MFDS grants the GIFT designation and the expedited review to ▲ drugs aimed at treating serious life-threatening diseases such as cancer or rare diseases ▲ drugs aimed at preventing or treating infectious diseases that may cause serious harm to public health, such as bioterrorism infectious diseases or pandemics, ▲ new drugs developed by Korea Innovative Pharmaceutical Companies designated by the Ministry of Health and Welfare, ▲ drugs used in combination with medical devices subject to expedited review, ▲ drugs that showed clinically significant improvements in effect over existing treatments or for which no existing treatment exists. Lamzede is a global orphan drug for which there are no existing therapies and was granted Priority Review (PR) by the US FDA on February 16, and was granted approval under the Marketing Authorisation Under Exceptional Circumstances (MAEC) program by the European Medicines Agency (EMA) in March 2018. Kwang Dong Pharmaceutical signed an exclusive domestic sales and distribution contract with the Italy-based global pharmaceutical company Chiesi Farmaceutical in July this year. Under the agreement, Kwangdong Pharmaceutical partnered with Chiesi Farmaceutici, for the exclusive sales distribution of Chiesi’s three rare disease drugs – Lamzede, Leber's neuropathy drug Raxone, and Fabry disease treatment Elfabrio – in Korea. The company plans to introduce Chiesi’s diverse lineup to the Korean market through the partnership agreement. In March, before partnering with Chiesi, the company had also signed an agreement with a Hong Kong opathamology drug company Zhaoke Ophthalmology to introduce the latter’s new drug candidate for pediatric myopia, 'NVK002,’ to Korea. Since the commencement of the program in September last year, a total of 23 products have been designated as GIFT products until now. Meanwhile, the first GIFT drug, Lunsumio (mosunetuzumab)’ has been approved in November this year. Drug subject to GIFT receives various support for the rapid commercialization of its product including at least a 25% reduction in the review period (ex: 120 working days → 90 working days), support for preparing approval data, rolling review support, and opportunities for close communication between the reviewer and developer and expert consulting on regulatory affairs, etc.
- Policy
- HER2-positive metastatic breast cancer drug Tukysa approved
- by Lee, Hye-Kyung Dec 15, 2023 05:51am
- The Ministry of Food and Drug Safety (MInister: Yu-kyoung Oh) approved two dosage forms (50mg, 150mg) of MSD Korea’s new breast cancer drug Tukysa (tucatinib) on the 14th. The drug is used in combination with trastuzumab and capecitabine, for patients with locally advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. Tucatinib is a tyrosine kinase inhibitor (TKI) that is a selective and potent inhibitor of the HER2 receptor overexpressed on cancer cells. It blocks the intracellular signaling pathway of HER2 to inhibit the survival, proliferation, and metastasis of tumor cells and induce cellular apoptosis The drug is expected to provide new treatment opportunities for HER2-positive patients who have been difficult to treat with existing therapies. MFDS said, "Based on our expertise in regulatory science, we will continue to make our best efforts to ensure that therapies with sufficiently confirmed safety and effectiveness are promptly supplied to expand treatment opportunities for our patients in Korea.”
- Company
- Reimb for Cold Agglutinin Disease drug Enjaymo starts in KOR
- by Eo, Yun-Ho Dec 15, 2023 05:51am
- The cold agglutinin disease treatment ‘Enjaymo’ is seeking reimbursement listing in Korea. According to industry sources, Sanofi Korea has filed a reimbursement application for its Enjaymo (sutimlimab) as a treatment for hemolysis in adult patients with Cold Agglutinin Disease (CAD) Enjaymo’ is a first-in-class humanized monoclonal antibody that is designed to selectively target and inhibit the classical complement pathway-specific serine protease, C1s. The drug was found to increase the CAD patients’ hemoglobin level and reduce profound fatigue. CAD is a very rare type of autoimmune blood disorder where part of the body’s immune system mistakenly continues to attack and destroy the body’s healthy red blood cells. When patients with CAD are exposed to a temperature below body temperature, they can experience▲ anemia due to chronic hemolysis, ▲ extreme fatigue, ▲ dyspnea, ▲ hemoglobinuria, ▲ acrocyanosis, and ▲ thromboembolism, with a median survival of 8.5 years after diagnosis. CAD is a very rare disease that develops in 1 in 1 million individuals. The number of CAD patients in Korea cannot be accounted for as the disease does not even have a disease code in Korea yet. Enjaymo has been approved in Korea based on the results of 2 clinical trials that demonstrated the drug’s efficacy and safety profile in adult patients with CAD. In the 26-week open-label, single-arm pivotal Phase III CARDINAL study that was conducted on 24 patients over 18 years of age, 54% of the patients (13/24) met the composite primary endpoint criteria - achieved normalization of hemoglobin (Hgb) level ≥12 g/dL or demonstrated an increase from baseline in Hgb level ≥2 g/dL at the treatment assessment time point and no blood transfusion from weeks 5 through 26 or medications prohibited per the protocol from weeks 5 through 26. Also in the 26-week randomized, placebo-controlled Phase III CADENZA study that was conducted on 42 adult CAD patients with one or less transfusion history within 12 months or no transfusion history within 6 months before enrollment, 42 patients were randomized to the Enjaymo arm (22) and placebo arm (20.) Study results showed that 73% of the Enjaymo arm (16/22) had showed an hemoglobin increase ≥1.5 g/dL at treatment assessment timepoint, avoidance of transfusion, and study-prohibited CAD therapy, whereas only 15% (3/20) achieved the same in the placebo arm. Based on the drug’s proven efficacy and safety profile, Enjaymo received the Orphan Drug designation, Priority Review, Breakthrough Therapy designation, and then officially approved the drug in February 2022. The drug was approved by the Japanese Ministry of Health, Labor and Welfare in June 2022, and by the European Medicines Agency (EMA) in November 2022.
