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- 2026-05-07 06:47:57
- Company
- Prostate cancer drug Pluvicto’s approval imminent in Korea
- by Eo, Yun-Ho Apr 24, 2024 05:44am
- The new metastatic castration-resistant prostate cancer drug ‘Pluvicto’ is set to soon be commercialized in Korea. According to industry sources, the Ministry of Food and Drug Safety is in the final stages of reviewing Novartis Korea's targeted radioligand therapy ‘Pluvicto (lutetium (177Lu) vipivotide tetraxetan)’ for its marketing authorization. Its formal approval is expected in the first half of the year. In June 2023, Pluvicto was recognized by the MFDS for its innovation and designated the drug as the 6th drug in the Global Innovative products on Fast Track (GIFT) program. In addition, Novartis has also applied to participate in the pilot approval-evaluation-negotiation linkage system with Pluvicto, which is expected to accelerate insurance reimbursement discussions after approval. Pluvicto is a radioligand therapy indicated for the treatment of prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy. It is regarded as a next-generation breakthrough therapy that delivers therapeutic radioisotopes to prostate cancer cells through the binding of radioisotopes (177Lu) and PSMA, triggering cancer death. The drug has been recognized for its innovation overseas as well, being designated as a Breakthrough Therapy and granted priority review, and quickly received FDA approval (March 2022). Meanwhile, Pluvicto’s efficacy has been demonstrated in the Phase III VISION study. In the Phase III VISION study, Pluvicto met both primary endpoints of OS and rPFS, reducing the risk of death by 38% and the risk of radiographic progression or death (rPFS) by 60% compared to standard of care monotherapy. In addition, approximately one-third (30%) of patients with evaluable disease at baseline demonstrated an objective response with Pluvicto+best standard of care (BSoC), compared to the 2% in the BSoC monotherapy arm
- Policy
- Prolia and Ryaltris adjust drug pricing
- by Lee, Tak-Sun Apr 23, 2024 05:40am
- Prolia. Amgen Korea and Chong Kun Dang Pharmaceutical will voluntarily reduce the price of 'Prolia,' which they are jointly selling. As the government expanded the administration guidance of osteoporosis medicines, Prolia, which is expected to see an increase in sales following the reimbursement expansion, voluntarily adjusted the ceiling price of the drug. Prolia recorded sales of KRW 151.1 billion last year (according to IQVIA), ranking second in the domestic pharmaceutical sales in Korea, following Keytruda. Some products, such as Yuhan’s 'Ryaltris Nasal Spray,' will lower the ceiling price due to increased usage. According to industry sources on the 22nd, the ceiling price of Prolia Prefilled Syringe (denosumab) will be reduced from KRW 162,600 to KRW 156,100 starting May 1st. This measure was taken as part of the reimbursement expansion. The government aims to support senior healthcare by increasing the reimbursable period to two years after treating osteoporosis, which has a preventative effect on bone fractures. The drug is currently reimbursable when the bone density is below -2.5 (T-score value). But starting in May, it is reimbursable for up to two years when the T-score is below -2.0 or up to -2.5. The expanded reimbursement scope is expected to benefit 44,773 patients. As part of the reimbursement scope expansion, the company selling Prolia voluntarily lowered the drug pricing under the agreement with the National Health Insurance Service (NHIS). The impact of the reimbursement expansion of osteoporosis medicines, following the voluntary drug pricing reduction, on the first annual finance is expected to be around KRW 5.6 billion. Prolia has dominated the osteoporosis medicine market since its domestic launch in 2017. Its co-promotion agreement with Chong Kun Dang Pharmaceutical yielded synergistic effects. In 2019, Prolia became the top-selling drug after receiving reimbursement coverage as a first-line osteoporosis treatment. This drug is a biologic that targets RANKL, which is essential for the formation, activation, and survival of bone-destructing osteoclasts. Last year, Prolia was ranked second among the medicines with the highest performance in South Korea. According to IQVIA’s report on sales figures, Prolia recorded sales of KRW 151.1 billion, second only to the anticancer immunotherapy drug Keytruda, which generated KRW 398.7 billion. Its voluntary price reduction is anticipated to relieve the patients’ co-payment burden and save National Insurance funds. Ryaltris. Meanwhile, Yuhan’s allergic rhinitis treatment, 'Ryaltris Nasal Spray (momethasone furoate/olopatadine),' which was included in reimbursement, saw a more than 30% increase in claimed amount compared to the expected amount. As a result, the reimbursement ceiling price was adjusted under the negotiated agreement based on the price-volume agreement (PVA, Type GA). Initially, an agreement was reached during the drug pricing negotiations for an expected claim amount of KRW 1.02 billion for this drug. However, it is expected that the actual sales will exceed this amount. Based on the outpatient prescription sales reported in last year's UBIST data, it was KRW 3.3 billion. Starting in May, the price of Ryaltris Nasal Spray (18 mL) will be adjusted from KRW 6,197 to KRW 5,893, and Ryaltris Nasal Spray (31 mL) will be adjusted from KRW 12,396 to KRW 11,789.
- Company
- Pharmbio wins over Novartis’ Revolade in patent dispute
- by Kim, Jin-Gu Apr 23, 2024 05:37am
- Pharmbio Korea has won the first trial in a patent dispute over Novartis' 'Revolade.' Pharmbio Korea has won the first trial in a patent dispute against 'Revolade (eltrombopag olamine),' a treatment for primary immune thrombocytopenia (ITP), following SK Plasma. Pharmbio Korea received a generic biological license application (BLA) prior to winning the first trial, but the company may face a high risk in launching the product. It is highly possible that the patent holder, Novartis, will appeal to the verdict. According to industry sources on the 22nd, the Intellectual Property Trial and Appeal Board (IPTAB) decided on the validity of three Revolade formulation patents brought by Pharmbio Korea against Novartis, issuing a favorable ruling on the claim validity on the 19th. There are five patents for Revolade, including two substance patents and three formulation patents. The substance patents expired in August 2021 and May of last year, while the remaining three formulation patents are set to expire in August 2027. In July last year, Pharmbio Korea filed for passive confirmation of scope of rights for three patents. SK Plasma filed a similar suit in the same month, following Pharmbio Korea. While Pharmbio Korea was the first to file the petition, SK Plasma secured a victory decision two months before. On January 31, SK Plasma received the decision to establish their claim. Pharmbio Korea has already obtained a generic BLA for Revolade. In March last year, it received a BLA for two doses of 'Korea Pharmbio Eltrombopag Olamine Tab.' SK Plasma has not yet completed the development of the generic. Pharmbio Korea has secured a BLA for a generic product, but launching it may pose challenges despite winning the first trial. This is because Novartis is anticipated to appeal. Novartis has already filed a lawsuit to cancel the decision after the first trial against SK Plasma in a similar patent dispute. Given Novartis' loss to Pharmbio Korea in the same patent dispute, there are similar expectations that Novartis will appeal to the IPTAB in the pharmaceutical industry. Revolade is a primary immune thrombocytopenic purpura (ITP) treatment developed by Novartis. ITP is an autoimmune disease in which the immune system attacks platelets as if they were foreign substances. Revolade treats this disease by stimulating platelet production. Initially developed by GSK, Revolade's patent and product rights were transferred to Novartis when GSK sold its oncology division to Novartis. In 2010, Revolade was approved in Korea as a treatment for patients with ITP, and in 2018, it was additionally approved for severe aplastic anemia indications. The following year, Revolade's sales saw significant growth after its reimbursement scope expanded to include severe aplastic anemia. According to pharmaceutical market research firm IQVIA, Revolade's sales, which were less than KRW 4 billion until 2018, increased to KRW 4.9 billion in 2019, KRW 7.6 billion in 2020, KRW 8 billion in 2021, and KRW 8.6 billion in 2022. Last year, it recorded sales of KRW 9 billion, a 5% increase from the previous year.
- Policy
- HK inno.N starts developing a Lixiana generic
- by Lee, Hye-Kyung Apr 23, 2024 05:36am
- HK inno.N is joining the race to develop a generic version of the NOAC (novel oral anticoagulant) drug Lixiana (edoxaban). The Ministry of Food and Drug Safety recently approved clinical trials to evaluate the bioequivalence of the Lixiana generic ‘IN-G00002’ and IN-R00002 (Lixiana). The IN-G00002 bioequivalence trial will evaluate the candidate’s efficacy in ▲reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF); ▲treating deep vein thrombosis and pulmonary embolism, and ▲reducing the risk of recurrence of deep vein thrombosis and pulmonary embolism. The clinical trial will be conducted at Suck Kyung Medical Foundation Central Hospital from July this year to July next year, and involve 60 adults aged 18 and older. Although Lixiana's patent expires on Nov. 10, 2026, the drug's PMS (post-marketing surveillance) period ended on Aug. 24, 2021, leading to applications for approval of follow-on drugs. Hanmi Pharmaceutical, Kolmar Korea, HK inno.N, Kolmar Pharma, Hutecs Korea, Chong Kun Dang, Samjin Pharm, Dong-A ST, and Sinil Pharmaceutical filed a passive trial to confirm the scope of the composition patent that expires on August 21, 2028, and received a confirmation in July 2020. As a result, 29 generics have been approved, starting with Dong-A ST's Edoxia ODT in December 2021. However, the substance patent for Lixiana is valid until November 10, 2026, so there are still 2 more years left before the generics can be released into the market. Against this backdrop, the NOAC market has been growing constantly. According to the market research institution UBIST, the NOAC market, which was worth KRW 147.2 billion in 2018, reached the KRW 200 billion mark in 2021, posting KRW 222.9 billion. In 2022, the market expanded further to KRW 242.5 billion.
- Company
- Skyrizi approved for palmoplantar pustulosis
- by Son, Hyung-Min Apr 23, 2024 05:36am
- Yoo Sang Baek, Professor of Dermatology at Korea University Guro Hospital Whether Skyrizi will be able to address the patients’ unmet needs for patients with palmoplantar pustulosis with its ease in administration is receiving attention. As a maintenance therapy, Skyrizi can be administered every 12 weeks, making it easier to dose than other treatments. Doctors have analyzed that the use of such new biological agents would be highly useful for patients with palmoplantar pustulosis, as existing treatments had little effect until now. On April 22, AbbVie Korea held a press conference at Andaz Hotel in Apgujeong, Seoul, to celebrate the approval of Skyrizi, a psoriatic disease treatment, for palmoplantar pustulosis. Skyrizi is a biologic agent developed by AbbVie that inhibits interleukin (IL)-23, and the drug was approved for the treatment of palmoplantar pustulosis on the 9th, extending its indication. Skyrizi inhibits IL-23, which is involved in inflammation and has been shown to be effective in several chronic immune-mediated diseases, including psoriasis. Palmoplantar pustulosis is a condition characterized by rashes, blisters, red spots, and sterile pustules on the palms and soles, and is often accompanied by intense itching and pain. People with palmoplantar pustulosis may experience crusting, thickening, erythema, and other changes at the same time. 90% of people with palmoplantar pustulosis also have plaque psoriasis and psoriasis on other parts of the body at some stage of the disease. In particular, these patients are particularly challenged by frequent disease exacerbations, partial remissions, and recurrence. Depending on the severity of the disease, topical pharmacotherapies, phototherapy, and systemic oral medications have been used to treat palmoplantar pustulosis, but have seen little effect. This is why whether the indication extension granted for Skyrizi will address the unmet need for patients with palmoplantar pustulosis is receiving attention. The indication extension to palmoplantar pustulosis was based on the results of the JumPPP study, a Phase 3 clinical trial conducted in Japan to evaluate the efficacy and safety of Skyrizi in 119 adult patients with moderate-to-severe palmoplantar pustulosis. Results showed that Skyrizi achieved a mean reduction in PPPASI (Palmoplantar Pustulosis Area and Severity Index) of -11.96, compared to -8.48 in the placebo arm. The PPPASI achievement rate at Week 16 was 41.4% for Skyrizi and 24.1% for placebo. Symptom improvement with Skyrizi was maintained through Week 68. As maintenance therapy, Skyrizi can be administered every 12, providing convenient dosing. Yoo Sang Baek, Professor of Dermatology at Korea University Guro Hospital, said, “The advantages of Skyrizi are in its significant effect in treating psoriatic disease and convenient dosing of 4 times a year. There are other treatment options, such as guselkumab, but they are not covered through a special health insurance co-payment calculation rate, thereby incurring a much out-of-pocket cost. Some patients revert to their previous treatment due to financial difficulties. This is why it is important to have a number of new treatment options available."
- Company
- Novartis fosters innovative talent through focus on purpose
- by Eo, Yun-Ho Apr 23, 2024 05:36am
- Novartis Korea has gone through a period of transformation over the past few years. As part of the global headquarters' large-scale reorganization, the company's long-established oncology and pharmaceutical businesses were merged. Although the businesses were operating under one name, Novartis, the two departments were operated independently. In fact, Marketing and Sales, as well as supporting departments such as Market Access, Government Affairs, and Licensing, were all organized separately. However, through the integration process, all of the departments were merged into one and led by a single head. As a result, a general manager of the integrated corporation was appointed for the first time since its establishment, and Novartis Korea was reborn. Dailpharm interviewed Hyunhee Lee, head of People & Organization (P&O) at Novartis Korea, a company that has been leading the innovative new drug business, including gene therapy drugs represented by CAR-T drugs, about the company's vision, ideal talent, and welfare benefits. Hyunhee Lee, head of People & Organization (P&O) at Novartis Korea-Could you first briefly introduce us to Novartis Korea? Globally, Novartis has approximately 78,000 employees in 143 countries. We have about 500 people at Novartis Korea. About half of our employees are internal staff, and the overall gender ratio is 52% female and 48% male. The ratio of female managers is 64% and the ratio of female executives is 68%, which is high among global companies. The average age of our workforce is 40, with around 60% of the workforce belonging to the MZ generation. The number of employees reaching retirement age at Novartis is also increasing. While we can't generalize, there have been cases where we extended the retiring employees’ terms of service through contract positions based on company and individual needs. I think it’s now time to think about career programs that fit the aging workforce. - Novartis has a significant number of female executives, which may partially be because the company is a multinational company. I think our culture encourages diversity and inclusion, and Novartis has a strong culture of employee ownership and initiative - a culture where you can be yourself and reach your full potential. There are a number of career development trainings, platforms, and sessions for women, including the Accelerating Women Leadership Program (AWLP). We also plan succession and talent reviews in a way that emphasizes diversity, including gender balance in the process of appointing executives and managers. The company culture is also very horizontal. All executives including the CEO listen to employees and emphasize an employee-driven and ownership culture. -What kind of employee does Novartis look for? Novartis' mission is to "Reimagine Medicine, Together.” The most important aspect of the company's mission is to find people who are motivated by the company's goal of reimagining medicine to improve and extend the lives of patients. Our 4 corporate behavioral values are summed up as ICUI, which stands for Inspired, Curious, Unbossed, and Integrity. In other words, we are looking for people who align with and practice these 4 behavioral values. – What are the qualifications for new hires, and what is the hiring process like? Also, what is the criteria for applying for an experienced position? e We do not have a regularized process for large-scale new recruitments. We hire applicants with the necessary experience and qualifications for each job and function ad hoc. We do not have any specific educational requirements or mandatory qualifications (such as English language certifications or recognized certification scores). However, in general, we conduct three rounds of interviews after the initial screening, including one English interview. -Many university students these days hope to join a multinational pharmaceutical company. Do you have any advice for university students who are interested in joining Novartis (excluding nurses, pharmacists, etc.) We are not actively recruiting new college graduates, but we have had intern programs in the past and it is one of our priorities this year. We are also planning to organize career fairs to help university students get to know Novartis better. My advice to university students who are interested in joining Novartis would be to prepare a story about a project or task that they have worked on on their initiative and derived results. It is important that they have taken ownership and initiative, and that they can tell their own story about a result that they have made from start to finish. We often call this an 'Elevator Speech', or ‘Elevator pitch,’ for example, it would be good to be prepared to explain your story in a short time, like when you take the elevator from the 1st floor to the 49th floor where Novartis Korea is located, in case you have that opportunity to talk to an influential person in the elevator. With so many different stakeholders involved in our industry, communication skills are also very important. It's important to develop a persuasive communication style that brings collaborative synergy. -What programs do you offer for the employees’ self-development once they are hired? As part of Novartis' purpose-driven corporate culture, we are committed to creating a workplace where employees are encouraged to think about why they do what they do and how they can take ownership of their work. First, ‘Make Your Move’ is an initiative that allows employees to explore and experience work across departments. We have an open internal recruitment system, with opportunities to move to other departments at any time, resulting in an internal hiring rate of over 60%. Talent Brokering is held monthly globally and monthly in APMA (Asia Pacific, Middle East, and Africa). Each country is transparent about open roles or availability of short-term – 3-month, 6-month, and 1-year - projects. We've created a practical platform for our employees to use as bridgeheads for their careers beyond the local region, and discussions are always ongoing within the platform. Last year, employees in Korea had the opportunity to participate in more than 6 regional and global projects, and as Novartis Korea rose to become one of the top 10 countries in the world, employees from various regions such as those from the Swiss headquarters have also applied to come to Korea to test their skills. - What reward programs or incentives do you have? Incentives are given based on sales targets. For departments other than sales, there are separate bonuses allocated based on base salary for each job and position, which are weighted by company performance and individual performance. In addition to the sales awards, Novartis has a reward system called ‘GEM (Go the Extra Mile),’ which looks for gems that align with key pillars of our strategy. In addition, we have a variety of other recognition programs, including the Star Awards given at the APMA regional level and the CEO Field Awards, for which employees are invited to the Novartis Basel headquarters to meet with Chairman Vas Narasimhan. We also have a Spark program in place to encourage and reward employees throughout the year. The reward system utilizes points that can be cashed in to encourage organic collaboration between departments. - Is there a limit for annual salary increases? Novartis conducts an annual market wage survey to determine the market value of compensation for each role and job code based on a market-based approach to compensation and recommends a compensation range of 70-130% of the market median, but there is no set limit. -How is the evaluation process done, since half of the positions are internal positions? We have eliminated the traditional rating-based personnel evaluation system and have established a feedback-based evaluation culture. At least once every quarter, managers and employees exchange feedback on the employees’ performance and seek ways for improvement. - We also want to know about the company's welfare benefit system. The company's welfare policies emphasize individual autonomy. We offer flexible and hybrid work arrangements so you can choose where you work. Also, new hires receive a special 5-day paid vacation. This is to give them time off to rest during the closing period around Christmas to the beginning of the year. We offer at least 21 vacation days, which is 15 statutory vacation days plus 6 days, which increases by 1 day every 2 years up to 34 days. Maternity leave is 98 days, 8 days more than the stipulated 90 days, and male employees can also take about 14 weeks of paid paternity leave when their spouse gives birth. In addition to the leave system, there are welfare programs such as kindergarten support for preschoolers and full tuition support for middle, high school, and university, as well as various family-oriented programs and events. In addition, the company has several employee-led programs in place, including establishing ‘N-chive,’ a one-stop archive for company policies, internal processes, and in-house programs.
- Policy
- Atopic dermatitis drug Adtralza will be reimb in May
- by Lee, Jeong-Hwan Apr 22, 2024 05:45am
- Leo Pharma Korea’s atopic dermatitis treatment, Adtralza (tralokinumab), will be reimbursed from May 1 in Korea. The reimbursement standards for osteoporosis drugs will also be improved, and patients who show some improvement in bone mineral density will be able to continue receiving reimbursement. As such, JW Pharmaceuticals' iron injection Ferinject will also be reimbursed. On the 19th, the Ministry of Health and Welfare issued an administrative notice of the 'Partial Amendment to the Details on the Standards and Methods for Applying Medical Benefits (Pharmaceuticals)' that contained the contents above. It will collect opinions until the 23rd for its implementation on the 1st of next month. The new drugs covered by the reimbursement through the administrative notice are Adtralza, a drug for atopic dermatitis, and Ferinject, an iron injection. Adtralza is a humanized monoclonal antibody that binds to interleukin-13. It controls atopic dermatitis by inhibiting downstream interleukin receptor signaling that triggers the inflammatory response. Adtralza is reimbursable for the treatment of chronic severe atopic dermatitis in adults (18 years and older) and adolescent patients (12 years to 17 years of age) whose condition has remained symptomatic for at least 3 years. Patients must have received at least 4 weeks of topical therapy (at least moderate-potency corticosteroids or calcineurin inhibitors) as a first-line treatment but were unable to adequately control their condition, followed by at least 3 months of systemic immunosuppressive agents (cyclosporine or methotrexate) that did not result in a 50% or greater reduction in Eczema Area and Severity Index (EASI) or were unable to continue their use due to side effects. Patients with an EASI of 23 or greater prior to Adtralza use are recognized as eligible for reimbursement. However, the patient should be able to confirm a history of topical and systemic immunosuppressive therapy within 6 months before initiating treatment with Adtralza for reimbursement. After 14 weeks of Adtralza treatment, if a patient’s EASI is reduced by 75% or greater at the 16th-week assessment, the patient may continue to use Adtralza with reimbursement for 6 additional months. Patients will continue to be evaluated every 6 months thereafter and may maintain their reimbursed status if they maintain their initial results. Inpatient prescriptions are required in principle, and a maximum of 4 weeks’ supply is allowed to be prescribed per single prescription upon discharge for outpatient use. However, a maximum of 8 to 12 weeks' supply is allowed for patients with stable disease activity and no adverse events after 24 weeks from the initial dose, and switching between Adtralza and the JAK inhibitor Dupixent is not allowed. The reimbursement standards for osteoporosis treatments have been extended to allow borderline patients who have reached their T-score treatment goal to continue to be eligible for reimbursement. As a result of clinicians and academic society input, patients who have been recognized to be eligible for reimbursement for a T-score of -2.5 or less (T-score≤-2.5) when measuring bone mineral density using Dual-Energy X-ray Absorptiometry (DXA) of the central bone, will be eligible for an additional year of reimbursement if their T-score improves during treatment to a T-score greater than -2.5 but less than or equal to -2.0. If the T-score remains greater than -2.5 but less than or equal to -2.0 thereafter, reimbursement will be allowed for another year. In the additionally approved period, patients will be allowed to switch between raloxifene, bazedoxifene, bisphosphonate, and denosumab. The patients may also switch to zoledronic acid injections. Lastly, the MOHW added the iron injection Ferinject to the reimbursement standards. However, it excluded Ferinject’s use in patients with chronic kidney disease on dialysis from the reimbursement standards.
- Policy
- KMPG ‘We ask for the prompt reimbursement of Xpovio’
- by Kim, Jung-Ju Apr 22, 2024 05:45am
- Patients’ demand for the reimbursement listing of ‘Xpovio 20mg (selinexor),’ a new drug for multiple myeloma that was developed by the Chinese pharmaceutical company Antengene, is growing. The patients are claiming that they are becoming ‘medical poor’ due to the delay in the reimbursement of the only option available in the area. Xpovio’s reimbursement agenda has been stuck at the reimbursement stage for more than 3 years since it was approved in Korea and is being delayed without a viable alternative. The Korea Multiple Myeloma Patient Group issued a statement on the 19th and strongly urged the authorities to consider the patients’ situations. The KMPG chairman said, "We strongly urge the Drug Reimbursement Evaluation Committee, which will meet in May, to expedite the reimbursement of Xpovio, the only light of hope remaining for the fading flickers of life for our multiple myeloma patients.” Multiple myeloma is a blood cancer caused by the abnormal differentiation and proliferation of plasma cells, a type of white blood cells responsible for the immune system, in the bone marrow. Xpovio Tab 20mg, which was developed to treat the disease, was approved by the MFDS and introduced to Korea on July 29, 2021. On June 14, 2023, the drug’s reimbursement application passed HIRA’s Cancer Disease Review Committee but suffered a setback right before its reimbursements when it was deemed non-reimbursable by DREC in November of the same year. Min-Hwan Baek, Chairman of KMPG, said, “Xpovio is currently being reimbursed in not only the A8 countries but A9 countries, being granted reimbursement in the United States, Germany, Canada, the United Kingdom, and Australia. But in Korea, patients are dying due to the drug’s non-reimbursement. I lay awake night after night as chairman of KMPG, worrying about the patients who are dying needless deaths due to lack of other options than the non-reimbursed, unaffordable Xpovio.” "It has come to the point where many patients who turned medical poor due to Xpovio’s non-coverage are giving up on treatment," said KMPG, urging for the prompt reimbursement of Xpovio.
- Company
- AstraZeneca focuses on improving competitiveness of NMOSD
- by Eo, Yun-Ho Apr 22, 2024 05:45am
- (From upper left) Soliris, Ultomiris. AstraZeneca focuses on improving the competitiveness of neuromyelitis optica spectrum disorder (NMOSD) treatments. The company aims to target the market as its new blockbuster drugs, 'Soliris (eculizumab),' which is used to treat paroxysmal nocturnal hemoglobinuria (PNH), and 'Ultomiris (ravulizumab),' which is a treatment for neuromyelitis optica spectrum disorder (NMOSD), expand indications. In 2021, Soliris received approval for an expanded indication for NMOSD in South Korea. After a prolonged discussion about its listing for insurance reimbursement, Soliris can now be reimbursed for insurance under expanded criteria starting this month (April). The specifics of reimbursement criteria include adult NMOSD patients aged 18 and above who test positive for anti-aquaporin-4 (AQP-4) antibodies, with at least two symptom relapses within the past year or at least three relapses within the past two years (including at least one relapse in the past year). Soliris can be prescribed when 'Mabther (Rituximab)' or ' Enspryng (satralizumab)' treatment cannot be continued due to relapses or side effects following administration. In terms of Ultomiris, after a failed attempt last September, it secured U.S. FDA approval for an additional indication last month. Ultomiris has a higher adherence rate than Soliris. While Soliris requires injections every two weeks, Ultomiris is administered every eight weeks, resulting in longer intervals between doses. The expansion of Ultomiris indications is based on the global Phase 3 CHAMPION-NMOSD study results. During the 73-week treatment period (median value), none of the patients who received Ultomiris relapsed, resulting in a reported 98.6% reduction in relapse risk compared to the control group. On average, NMOSD is a chronic autoimmune disorder that affects the central nervous system. It is estimated to impact approximately 200,000 people worldwide and is more commonly found in women aged 30 to 40. Initially recognized as a variant of multiple sclerosis, a chronic inflammatory demyelinating disease of the central nervous system, NMOSD was distinguished from multiple sclerosis upon the discovery of disease-specific antibodies (aquaporin-4 [AQP4]-IgG) in opticospinal myelitis patients' serum. According to the Korean Society of Neuroimmunology, as of 2017, about 3.56 individuals per 100,000 are estimated to be affected by NMOSD. It is estimated that there are over 1,000 NMOSD patients in South Korea. The average onset age of NMOSD in South Korea is reported to be 43 years old, with a prevalence that is 4.7 times higher in females than in males.
- Policy
- Will the 37th new drug in Korea receive approval?
- by Lee, Hye-Kyung Apr 22, 2024 05:45am
- Jeil Pharmaceutical. The approval for the 37th new drug in Korea is approaching. According to industry sources on the 22th, the Ministry of Food and Drug Safety (MFDS) completed the safety and efficacy assessment of the three zastaprazan-containing products from Onconic Therapeutic, Jeil Healthscience, and Jeil Pharmaceutical. The completion of the safety and efficacy assessments by MFDS indicates that approval is nearing. Jeil Pharmaceutical simultaneously applied for new drug approvals from three affiliated companies, including Jeil Healthscience, which manufactures over-the-counter drugs, and its subsidiary, Onconic Therapeutic, which specializes in new drug R&D. These three products contain the active ingredient of zastaprazan. Upon completion of the safety and efficacy assessment by MFDS, approval for these three products is anticipated. In June last year, Onconic Therapeutic submitted the New Drug Application (NDA) to the MFDS for domestic launch. The NDA was based on the Phase 3 clinical trial, which evaluated 298 patients with gastroesophageal reflux disease (GERD) in 28 medical facilities in South Korea. Notably, there has not been a single case of MFDS-designated new drug in South Korea following the 36th new drug in Korea, 'Envlo,' in November 2022. Therefore, approval of zastaprazan would lead to approval of new drugs in South Korea. Zastaprazan is a new drug that belongs to the class of novel potassium-competitive acid blocker (P-CAB). P-CAB is expected to replace the proton pump inhibitors (PPI) in the anti-peptic ulcer drug market, including the treatment for gastroesophageal reflux disease (GERD). P-CAB class products in Korea include HK inno.N’s 'K-CAB,' the 30th new drug in Korea, and Daewoong Pharmaceutical’s 'Fexuclue,' the 35th new drug in Korea. According to medical market research firm UBIST, K-CAB recorded prescription sales of KRW 30.4 billion in 2019. Sales grew rapidly to generate KRW 77.1 billion in 2020, KRW 110.7 billion in 2021, and KRW 132.1 billion in 2022. Since its launch in July 2022, Fexuclue has recorded cumulative prescription sales of KRW 61 billion up to November 2023, changing the market paradigm for gastroesophageal reflux disease.
