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- 2026-04-09 06:29:33
- Policy
- Final PVA improvement plan to be prepared soon
- by Lee, Tak-Sun Oct 27, 2023 05:33am
- The final plan to improve the price-volume linkage system is expected to be prepared soon. Most of the improvement plans are expected to reflect the research service results that were released last April. According to industry sources on the 26th, the National Health Insurance Service will complete the public-private working group activities that have been held since June will be completed with the last meeting held on improving the usage-drug price linkage system in early November The NHIS plans to prepare a final draft after the completion of working group activities and aims to revise the internal guidelines with the goal of implementing it on January 1 next year. Accordingly, the final draft is expected to be released at the end of the year. The revision to the internal guidelines is likely to raise the claims amount standard for drugs subject to PVA price cut negotiations from KRW 2 billion to KRW 3-4 billion. If this happens, lower-performing products will likely be relieved of the burden of relieving drug price cuts. However, the other measures that require notification will be implemented later. Industry experts expect the changes such as increasing the maximum reduction rate currently restricted to 10% and including items with an increase in claims amount of more than 10% and KRW 5 billion to be subject to PVA negotiations, to be made by the first half of next year. Meanwhile, changes to the PVA system as a preferential measure for innovative new drugs that had been discussed may also likely be included in the final draft. The price reduction rate for innovative new drugs that are subject to PVA will be reduced if the same drug is subject to PVA three times in a row. Last year, the NHIS carried out an external research service on practical measures to improve Korea’s drug expenditure management system, and its result report was released in April. 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, showed that the selection and management of drugs with large financial impact should be identified and that a more efficient operation of the system is necessary.
- Company
- The Key to Competitiveness is 'OS·Brain metastasis'
- by Oct 26, 2023 06:07am
- The combination therapy of major EGFR variant lung cancer treatments has yielded results at the annual conference of the European Society of Oncology (ESMO 2023). Combination therapy of Lexraza + Rybrevant has succeeded in improving major clinical evaluation indicators compared to Tagrisso monotherapy. Lexraza is a lung cancer treatment that targets the EGFR variant Exxon 19 and Exxon 21 L858R developed by Yuhan. We are confirming the possibility of a primary treatment for lung cancer in combination with Janssen's Exxon 20 target Rybrevant. Tagrisso, in combination with platinum-based chemotherapy, has released clinical results in which encephalon has been effective in lung cancer patients. Tagrisso is a third-generation tyrosine kinase inhibitor (TKI), such as Leclaza, which is used to treat primary and secondary lung cancer with EGFR mutations. After the failure of third-generation TKI treatment, platinum-based chemotherapy, which is mainly used for secondary treatment, is being used in combination with Tagrisso to evaluate its effectiveness. Published clinical results showed that one side did not show overwhelming results. The overall survival (OS) data to be released at a later date and the effectiveness of brain transfer in patients have become important. Leclaza+Rybrevant Improves key evaluation indicators for Tagrisso therapy. At ESMO 2023 on the 23rd, the results of an interim analysis of the MARIPOSA Phase 3 clinical study evaluating the efficacy of Leclaza+Rybrevant combination therapy were released. The clinical trial was conducted in 1074 patients with EGFR variant locally advanced or metaplastic non-small cell lung cancer. The patient age (median) was 63 years old and Asian patients accounted for more than half (59%). Among them, the rate of brain transfer was 41%. Patients were randomly assigned to a 2:2:1 ratio for Leclaza+Rybrevant combination therapy, Tagrisso monotherapy, and Leclaza monotherapy. The primary evaluation variables included no-progress survival (PFS), and the secondary evaluation variables included the OS, PFS (PFS2) after the first subsequent treatment, and ORR. As a clinical result, the PFS (median) of the Leclaza+Rybrevant group was 23.7 months and the Lexa monotherapy group PFS was 18.5 months, which was longer than the 16.6 months recorded by the Tagrisso monotherapy group. The Leclaza+Rybrevant group was found to have a 30% lower risk of disease progression and death than the Tagrisso group. ORR showed similar numbers, with Leclaza+Rybrevant groups and Tagrisso monotherapy groups at 86% and 85%, respectively. In the interim OS analysis, the Leclaza+Rybrevant group showed a favorable tendency over the Tagrisso monotherapy group. PFS2 results show that the Leclaza+Rybrevant group had a 25% lower risk of disease progression or death compared to the Tagrisso monotherapy group. In terms of safety, EGFR and MET-related adverse reactions have been more commonly reported in the Leclaza+Rybrevant group. Level 3 adverse events were reported at 75% and 43% in the Leclaza+Rybrevant and Tagriso monotherapy groups, respectively, and serious adverse events were reported at 49% and 33%. The adverse events that led to death were similar at 8% and 7%. Presenters at Presidential Session 3 held on the 23rd. Yonsei Cancer Hospital Professor Cho Byeong-cheol (left) introduced the results of the MARIPOSA phase 3 clinical trial. Photo source = ESMO DAILY REPORT Professor Cho Byung-cheol of Yonsei Cancer Hospital, who was in charge of the presentation on this day, said, "Recraza + Libribant combination therapy was effective regardless of race or race. In particular, as favorable tendencies have been confirmed in the OS mid-analysis, Leclaza+Rybrevant has suggested the possibility of becoming a new standard treatment for the new EGFR variant primary treatment for non-small cell lung cancer.” In the case of Tagrisso, data from a follow-up study of the FLAURA2 clinic was released. In the FLAURA2 clinical study, PFS of Tagriso+Platinum-based chemotherapy was recorded at 29.4 months. In ESMO 2023, the results of a subgroup analysis of patients were released. The results of a study released on the 21st showed that the combination of Tagrisso + chemotherapy for patients had a stronger inhibitory effect on intracranial progression compared to Tagrizo monotherapy. The clinical trial included 557 patients with EGFR-positive metaplastic non-small cell lung cancer who had no previous experience in general therapy. Among them, there were 222 patients with brain war. Patients were assigned to the combination therapy group (279 people) and the monotherapy group (278 people), respectively. As a clinical result, intracranial ORR in the co-therapy group was 73%, similar to 69% for monotherapy. However, the complete response (cEAS) in the two was 59% in the co-use group and 43% in the monotherapy group. The median intra-two non-progress survival (PFS) assessed by the Independent Review Committee (BICR) was 30.2 months for the combination therapy group and 27.6 months for the monotherapy group. The risk of disease progression or death in combination therapy was found to be 42% lower. The key evaluation element of combination therapy, 'OS·brain transfer effect' Leclaza+Rybrevant, Tagrisso +, and chemotherapy all differed in PFS. The OS data was still immature, but favorable tendencies were observed for both combination therapies. As the PFS difference is not significant, the OS data that will be released in the future will be the key to becoming the primary treatment for EGFR mutations for non-small cell lung cancer. It is also noteworthy that the two combination therapies have an effect on patients. PATIENTS WITH CEREBRAL EMBRACTION INCLUDED 43% IN THE MARIPOSA CLINICAL AND 40% IN THE FLAURA2 CLINICAL. It is known that anticancer drugs fail to pass through the Blood Brain Barrier (BBB) if the cancer has spread to the brain. Especially since encephaly occurs frequently in patients with lung cancer, the proportion of patients with epilepsy including epilepsy is emphasized in the two clinical trials that evaluate the effectiveness of combination therapy. The utilization of Leclaza+Rybrevant, Tagrisso + chemotherapy is analyzed and effective data will play a decisive role in patients with OS and Brain metastasis, which will be released at a later date.
- Company
- Seo Jeong-jin, targets sales of 5 trillion won for new drugs
- by Kim, Jin-Gu Oct 26, 2023 06:06am
- Celltrion Group Chairman Seo Jeong-jin is explaining future plans at a press conference on the 25th Seo Jeong-jin, Chairman of Celltrion Group, presented a goal to increase global new drug sales to 5 trillion won by 2030, focusing on 'Zymfentra', which was recently approved as a new drug in the United States. Chairman Seo made this announcement at a press conference held at NH Investment & Securities in Seoul on the 25th. Previously, Celltrion set the group's total sales target of 12 trillion won in 2030. The plan is to increase sales by adding new drugs as well as existing biosimilars. Chairman Seo predicted that Zimfentra would play a pivotal role here. Zymfentra is the subcutaneous (SC) formulation of Remsima. On the 20th (local time), it received sales approval as a new drug from the U.S. Food and Drug Administration (FDA). Previously, it was approved as a new formulation biosimilar in Europe, but in the United States, it took the route of new drug approval through a separate phase 3 clinical trial. Celltrion explains that since it has obtained approval as a new drug, it can set a higher sales price than existing biosimilars. Chairman Seo said, “We expect superior profits in the U.S. market compared to Europe, where RemsimaSC was previously approved as a biosimilar.” Chairman Seo said, "When RemsimaSC was sold in Europe, it was confirmed that 40% of patients who had previously used the intravenous formulation switched to the SC formulation within one year." He added, "If we apply this to patients in the United States, many patients will move to the SC formulation." “We expect that Zymfentra alone will be able to achieve global sales of 3 trillion won within 3 years,” he emphasized. He explained that he has also begun drug price negotiations with several insurance companies in the United States. It was expected that the drug price in the US market would be at the level of ‘competitive products’. He pointed out the competing product as Takeda Pharmaceutical's Entyvio. Entyvio is a treatment for autoimmune diseases such as ulcerative colitis and Crohn's disease. In the United States, it was previously approved as an intravenous injection formulation, but recently a subcutaneous injection formulation was also approved. It is said to be similar to Jim Pentra in many ways. Chairman Seo predicted, “Negotiations with insurance companies began in earnest yesterday. Negotiations will be completed within the year,” and added, “The US price of Zympentra is expected to be similar to that of Entyvio, a competing product.” Chairman Seo said, “Next year, we will also conduct a comparative clinical trial with Entyvio,” and added, “Entyvio conducted a comparative clinical trial with Humira, but not with Remsima. The existing animal clinical trials yielded meaningful results.” Chairman Seo said, "In addition to Zympentra, we have four new drug platforms. The related pipelines amount to 20," and added, "We expect that there will be no problem with global new drug sales of 5 trillion won by 2030, centered on Zympentra." He emphasized.
- Policy
- Minister Cho will work to address shingles vaccine issue
- by Lee, Hye-Kyung Oct 26, 2023 06:06am
- The government responded that it would seek ways to ease the public burden in response to the request that shingles vaccines should be included in Korea’s National Immunization Program (NIP). Rep Young-Joo Kim of the Democratic Party of Korea pointed at the audit of the NA Health and Welfare Committee that was held on the 25th. She said, “There are medical institutions that charge up to KRW 400,000 for shingles prevention vaccine, whose supply price starts at KRW 8,400. In addition to adding the vaccines to NIP, we need to take measures such as a price disclosure system for suppliers.” According to the data Rep Kim received from the KDCA and HIRA, the average price of Zostavax Inj in 2022 was KRW 165,471, ranging from KRW 90,000 to up to KRW 400,000. In 2021, the average price of vaccination in SKYZoster was KRW 146,358. Its price ranged from KRW 40,000 to KRW 230,000, which is a sixfold difference. From 2021 to August of this year, the average supply price of SKYZoster was around KRW 77,000 every year. The places that received the vaccines at the highest price during this period were found to have received them at KRW 341,000, KRW 161,000, and KRW 150,000 in 2021, 2022, and 2023, respectively. Rep Kim said, “People are receiving shingle vaccinations like a lottery. The ex-factory price is being set randomly, and those who lack information are left to receive the vaccination for KRW 400,000,” requesting countermeasures. In relation to this, Minister of Health and Welfare Minister Kyoo-Hong Cho said, "We have been disclosing the price of non-reimbursed items first because it is difficult to control their price. We will investigate the cause of the sharp drop in price and the price difference. The issue of its reimbursement through NIP needs to be reviewed on its medical necessity and financial efficiency. It is difficult to say no, so we will seek ways to alleviate the public burden." HIRA President Jung-Gu Kang, said, “We have been disclosing the non-reimbursed prices of drugs, and will expand the disclosed items to more than 1,000 in the future. We will try to find other means (to disclose ex-factory prices).” Commissioner Young-Mee Jee of the Korea Disease Control and Prevention Agency said, “We are currently evaluating introducing shingles vaccine to NIP. We will apply it as soon as the results are available. If it is listed as an NIP drug, the method of purchasing the vaccine will also be improved and be priced appropriately.”
- Policy
- Prostate cancer tx Xtandi·Zytiga, 5% pt copayment applied
- by Lee, Tak-Sun Oct 26, 2023 06:06am
- Mandatory coverage is applied to some treatments for prostate cancer treatments Xtandi soft capsule 40mg and Zytiga, which is expected to reduce the financial burden on patients. This is a measure of fairness as Erleada is subject to mandatory benefit as it was previously listed. The HIRA announced that it will revise the anticancer drug reimbursement standards including this information starting in November. Xtandi's pt copayment will be lowered from 30% to 5% due to expanded coverage for ADT combination therapy (first-line palliative treatment) for metastatic hormone-sensitive prostate cancer. Zytiga also lowers the pt copayment of prednisolone + ADT combination therapy (first-line, palliative treatment) from 30% to 5% for metastatic hormone-sensitive prostate cancer. HIRA said, "As Erleada, a drug in the ARTA (androgen receptor targeting agent) class, was recently applied for the same indication with a pt copayment of 5/100, issues such as confusion in actual clinical settings and patient equity were raised, so textbooks and guidelines were revised. · Referring to academic opinions, etc., it was judged to be a drug that needed expanded coverage, so the pt copayment was changed from 30% to 5%,” he explained. The upper limit amount was also adjusted according to the expansion of benefits. Zytiga has applied an ex officio adjusted upper limit amount as Hanmi Pharmaceutical's 'Abiteron 500mg', a generic drug, was listed starting this month. Accordingly, the upper limit will be reduced from 16,780 won per party, which is 70% of the previous highest price, to 11,746 won. After one year, it will drop to 8,986 won, which is 53.55%. For reference, Hanmi's first generic ‘Abiteron 500mg’ was listed at 8,537 won per tablet. The transition to mandatory coverage also greatly reduces the financial burden on patients. In the case of Xtandi, the cost per patient is reduced from about 5.84 million won to about 660,000 won per year, the NHIS said. Last year, based on IQVIA, domestic sales amounted to 29.1 billion won for Xtandi and 21.8 billion won for Zytiga.
- Policy
- Will restrictions be eased for vaccine clinical trials?
- by Lee, Jeong-Hwan Oct 26, 2023 06:06am
- Minister of Food and Drug Safety Yu-Kyung Oh promised to reduce or ease the mandatory participation rate of domestic clinical patients from the current 10% to 5% to strengthen sovereignty over domestically produced vaccines and increase self-sufficiency. The plan is to improve the current regulations by accepting the claims raised by domestic pharmaceutical companies that seek to develop domestic vaccines and agreeing with the National Assembly's suggestion to speed up development by lowering the domestic reference rate to reinforce actual vaccine self-sufficiency. On the 25th, Yu-Kyung Oh, Minister of Food and Drug Safety, responded as follows to an on-site inquiry made by Rep. Ki-Youn Kang of the People Power Party at the NA audit. Rep. Kang pointed out that vaccines to prevent diseases such as pertussis and cervical cancer are frequently sold out or out of stock domestically, thereby infringing on people's health and convenience. In particular, Rep. Kang pointed to the 10% domestic participation rate requirement set for clinical trials for vaccine development as the issue and urged it be lowered to 5%. Rep. Kang said, “South Korea, which ranks among the top 10 economies around the globe, is always low on vaccines. To secure sovereignty, the related R&D budget must be significantly increased. Also, the current 10% domestic participation rate required for vaccine clinical trials is very high compared to global standards. If this ratio is lowered to just 5%, the vaccine development period can be shortened by 2 to 3 years.” Rep. Kang added, “Please review the claim that the proportion of the Korean participants in the clinical trial should be lowered. The Ministry of Food and Drug Safety needs to ease regulations by actively listening to the pharmaceutical industry’s demands for vaccine development.” In response to Rep. Kang's criticism, MOHW Minister Kyoo-Hong Cho promised to secure the R&D budget necessary for vaccine development, and MFDS Minister Oh promised to push down the domestic participation rate requirement to 5% for vaccine clinical trials. Minister Cho said, “We will be able to better support vaccine sovereignty by introducing a new project called Korean ARPA-H in the 2024 budget. We will proceed according to plan.” Minister Oh said, “The 10% rate is not mandatory, but recommended. If the developer provides statistically valid evidence, the Korean participation rate can be adjusted flexibly.” When Rep. Kang requested easing of the regulation to 5%, Oh replied, “I will do so.”
- Company
- Verzenio reattempts reimb for early breast cancer in KOR
- by Eo, Yun-Ho Oct 26, 2023 06:06am
- Verzenio, the first CDK4/6 inhibitor to attempt reimbursement listing for early breast cancer, has begun its second journey toward reimbursement in Korea. This attempt is being made 5 months after the first failure. The news of Lilly Korea's Verzenio (Abemaciclip) reapplication for reimbursement was made known through a written inquiry made by Rep. Young-Seok Seo (Democratic Party of Korea) of the National Assembly Health and Welfare Committee to the Ministry of Health and Welfare during the NA audit. Rep Seo inquired about the status of reimbursement of drugs approved to prevent relapse in patients with early breast cancer and the MOHW’s position and plans regarding the application of coverage to related new drugs. Verzenio was mentioned as one of the 17 drugs that own an indication for early breast cancer in the response submitted by the MOHW. Other than the letrozole generic that is used as endocrine therapy, it is the only new drug for the HR+/HER2- type. The drug was first approved on November 18th, 2022 as an adjuvant treatment for adult patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-), node-positive, early breast cancer (EBC) at high risk of recurrence in combination with endocrine therapy. More specifically, a very limited range of patients with ▲ patients with 4 or more positive axillary lymph nodes, ▲ 1-3 positive axillary lymph nodes, and tumor size of 5 cm or larger, or ▲histological grade 3 disease. However, the drug struggled from the first step to its reimbursement at HIRA's Cancer Disease Review Committee level. After a long wait of 6 months after submitting the application, the agenda was finally reviewed at the 3rd CDDC meeting that was held on May 3rd. However, Verzenio had unfortunately many contestants. A total of 9 items were reviewed in the 3rd CDDC meeting. This was the largest amount of subjects among the 7 cancer screening meetings held this year. 5 months after failing the first CDDC review, Lilly filed for reimbursement again on October 4th to HIRA. The company was equipped with new supporting data presented at the 2023 ESMO Congress that had been held in Madrid, Spain recently. The 5-year morachE data that was released was a follow-up study of the 4-year data released at the San Antonio Breast Cancer Symposium published in Lancet Oncology in December 2022. Study results showed that the differences in the major clinical indicators - invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS) rates – widened more distinctively between the Verzenio arm and the control arm (endocrine therapy alone) at 5 years compared to 4 years. At 5 years, the primary efficacy endpoint IDFS differed by 8%. This means that even after completing Verzenio treatment during the limited period of 2 years after surgery, its treatment effect continued until the 5th year. This data is even more significant as the term, ‘cure,’ is generally used 5 years after cancer treatment. Powered by the reinforced data, the key now lies in the hands of the MOHW. In response to Rep. Seo's written inquiry regarding the coverage of new drugs to prevent early breast cancer recurrence, the MOHW’s Pharmaceutical Benefits Division said, "We strongly agree with the direction of helping early breast cancer patients receive timely treatment and enjoy a better life. We are committed to preventing early breast cancer recurrence. When drugs with indications to prevent early breast cancer recurrence apply for reimbursement, we will review them in accordance with procedures, taking into full consideration their cost-effectiveness, etc..”
- Company
- Janssen ‘will continue endeavors to the Korean society’
- by Son, Hyung-Min Oct 25, 2023 11:08am
- Janssen Korea held a press conference celebrating its 40th year of establishment at the Seoul Plaza Hotel on the 23rd Janssen, which has succeeded in developing treatments in various areas including mental health, autoimmune diseases, and oncology over the past 40 years, emphasized that it will continue to contribute to Korean society by providing innovative medicines and fostering talent. On the 23rd, the company held a press conference celebrating its 40th year of establishment at the Seoul Plaza Hotel. At the event, the company introduced the major achievements it had made in the past 40 years and their significance in each of its therapeutic areas. Managing Director of Janssen Korea Cherry Huang, as well as Chris Hourigan, the Company Group Chairman, Pharmaceuticals, Asia Pacific, Jung-Hee Lee, Chairman of the Board at Yuhan Corp., Professor Sang-Yeol Lee, President of the Korean College of Neuropsychopharmacology, and Young-Shin Lee, CEO of the Korean Research-based Pharmaceutical Industry Association, attended the event. During the four decades, Janssen Korea has provided its innovative drugs to patients in various fields in Korea, including oncology, autoimmune diseases, mental health, and pulmonary hypertension, According to data disclosed by the company, its market share of prescription drugs for autoimmune diseases that are used to treat plaque psoriasis, ulcerative colitis, and Crohn’s disease, has occupied, and is leading the ETC market for autoimmune diseases in Korea. Janssen also strengthened its position in the field of neurology. Its Invega (paliperidone), a treatment for schizophrenia, and Concerta (methylphenidate), a treatment for severe attention deficit hyperactivity disorder (ADHD), were also successfully launched in Korea. In oncology, the company announced its market entry by receiving domestic approval for its CAR-T treatment Carvykti (ciltacabtagene autoleucel) and lung cancer treatment Rybrevant (amivantamab). Janssen Korea is recognized as a global pharmaceutical company that has successfully introduced open innovation to Korea. Janssen purchased the global distribution rights to Yuhan Corporation’s Leclaza (lasertinib) in 2018. Leclaza was developed by Genosco, an American subsidiary of Oscotec, whose technology Yuhan Corp imported to Korea. Since then, Janssen has been evaluating the effectiveness of Leclaza in combination with Rybrevant in lung cancer treatment. The two-drug combination is likely to become a first-line treatment option for non-small cell lung cancer in the future. Jung-Hee Lee, Chairman of Yuhan Corp, who participated that day, highly evaluated Janssen. Yuhan also took the company’s value into consideration when deciding to select Janssen as its global partner and licensed out Leclaza’s technology. Lee said, “I have high respect for Paul Janssen, who founded the company. “Janssen’s philosophy of ‘respect for humanity’ was greatly taken into consideration when choosing a global partner for Leclaza.” Janssen pointed to activities such as fostering domestic talent and providing innovative medicines as measures it will pursue to coexist with Korean society in the future. For this, Huang expressed intentions to cooperate closely with the Korean government, HCPs, and industry officials. Cherry Huang, Managing Director of Janssen Korea, said, “Janssen Korea and will work together with Korea to envision and depict a future in which innovative medicines can be provided to more domestic patients and a future in which we can foster talents that can contribute to the Korean society. I hope we can go beyond the 40 years we have spent together and record another 10 years of history, even 100 years.” Chris Hourigan, the Company Group Chairman, Pharmaceuticals, Asia Pacific, said, “We have been investing in the development of treatments with high unmet needs and for the underprivileged in our society, We are also working closely with the Korean government, HCPs, and industry partners to lead the wave of innovation that can fundamentally tackle the way we deal with disease.”
- Company
- JW Pharma terminates contract after 5 yrs of atopy new drug
- by Chon, Seung-Hyun Oct 25, 2023 05:25am
- View of JW Gwacheon office building JW Pharma announced on the 20th that the technology transfer contract for 'JW1601', a treatment for atopic dermatitis, signed with Danish pharmaceutical company Leopharma, has been terminated. The company explained, “We have received a notice of termination of the contract from the Leopharma side and have agreed to return all rights.” JW1601 was transferred to Leopharma in the preclinical phase by JW Pharmaceutical in August 2018. The contract size is $42 million. JW Pharmaceuticals is a condition of receiving a non-refundable down payment of $17 million from Leopharma and up to $385 million sequential milestones for clinical development, licensing, commercialization, and sales. With this termination of the contract, the down payment of $17 million received by JW Pharmaceutical does not need to be returned. Leopharma began clinical phase 2a/b in December 2021 after the introduction of JW1601, and the trial ended last July. JW Pharmaceutical explained that Leopharma has not met the primary evaluation indicators in the initial key results of global clinical phase 2a/b. JW Pharmaceutical said, "Tolerability has been confirmed in all drug dosing groups, and no new safety issues or concerns have been identified. Safety has also been confirmed in the results of clinical trials related to heart safety that were conducted separately." JW1601 has a dual mechanism of action, which selectively acts on the histamine H4' receptor, blocks the activity and movement of immune cells that cause atopic dermatitis, and inhibits the signaling of histamine, which causes itching. Histamine H4 is a receptor that regulates the movement and activity of inflammatory cells and regulates itching signaling, and is evaluated as a target that can fundamentally solve the pathological causes of atopic dermatitis. JW Pharmaceutical emphasized, “Based on the drug's properties that selectively act on the H4 receptor of histamine and the safety region that has been confirmed in clinical practice, we plan to review the future development direction, including the possibility of new indications,” JW Pharmaceuticals.
- Company
- Combo drugs strong in the COPD treatment market
- by Son, Hyung-Min Oct 25, 2023 05:24am
- The growth of the combination drugs was notable in the chronic obstructive pulmonary disease (COPD) treatment market in Q3 this year. With major COPD treatment guidelines recommending a long-acting muscarinic antagonist (LAMA) and long-acting beta2 agonist (LABA), the prescription trend appears to have shifted toward combination drugs. In particular, the growth of the LAMA+LABA combination drugs owned by GlaxoSmithKline (GSK) and Boehringer Ingelheim (BI) had stood out. Presciptions of LAMA+LABA combos (Source: UBIST). According to the market research institution UBIST on the 23rd, the amount of outpatient prescriptions for LAMA+LABA combination drugs in Q3 amounted to KRW 10.3 billion. This is a 10.8% YoY increase from last year. The bronchodilators LAMA and LABA are used to improve lung function in COPD patients. Anoro, a LAMA+LABA combination drug developed by GSK, recorded KRW 5.5 billion in prescriptions in Q3 this year, a 17.0% YoY increase compared to the same period of last year. Anoro’s sales have been steadily increasing since 2018, recording over KRW 10 billion every year. Anoro is a LAMA+LABA combination drug that was first released on the market in 2015. Boehringer Ingelheim's Vahelva's prescriptions rose 11.5% YoY to record KRW 2.9 billion, contributing to the rise in prescriptions in the LAMA+LABA combination drug market. Prescriptions of major LAMA+LABA COPD treatments (Source: UBIST) On the other hand, single-agent drug prescriptions had slowed down. Onbrez, a LABA single-agent drug developed by Novartis, was prescribed only worth KRW 130 million in Q3 this year. Onbrez’s sales have not exceeded KRW 1 billion in annual sales ever since 2021. Sales of LAMA single-agent drugs also showed a downward trend. Prescriptions of Boehringer Ingelheim's Spiriva increased to KRW 2.7 billion in Q3 this year. This is a 28.9% decrease from the KRW 3.8 billion recorded in the same period last year. GSK's Incruise also recorded KRW 970 million in Q3, down 30.7% YoY. Prescriptions of LAMA+LABA combinations are on the rise because of their effectiveness. In clinical trials that were conducted on COPD patients, combination drugs improved lung function by more than 2 times compared to single-agent drugs. Favorable results were also observed in major indicators such as lung function and shortness of breath. Analysts also have suggested that the COPD treatment guidelines have also contributed to the increase in prescriptions for LAMA+LABA combination drugs. The updated 2023 COPD treatment guidelines by the Global Initiative for Chronic Obstructive Lung Disease (GOLD), prioritized the use of LAMA+LABA combinations. GOLD recommended LABA+LAMA combination therapy or combination drugs for COPD treatment rather than LABA or LAMA monotherapy. The ICS + LABA combination therapy, which was previously recommended for treatment when the blood eosinophil count was over 300, was replaced by the LABA + LAMA + ICS combination therapy. The domestic COPD treatment guidelines also recommend prior use of LABA+LAMA combination drugs.
