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- 2026-04-13 10:24:09
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- Opdivo combo in review for esophageal cancer indication
- by Eo, Yun-Ho Nov 24, 2021 05:53am
- The cancer immunotherapy ‘Opdivo’ is attempting to add another esophageal cancer indication as a combination therapy in Korea. According to industry sources, the Ministry of Food and Drug Safety is reviewing expanding the indication for Ono·BMS’s PD-1 inhibitor Opdivo (nivolumab) in combination with Yervoy (ipilimumab) or chemotherapy as first-line treatment for unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma. The combinations are under review by the EU EMA for the same esophageal cancer indication. The efficacy of the Opdivo-based combination therapy as first-line treatment in esophageal cancer was demonstrated through the Phase III CheckMate-648 trial. In the trial, the two Opdivo-based treatment combinations (Opdivo+chemotherapy and Opdivo+Yervoy) demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit compared to chemotherapy in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma with tumor cell PD-L1 expression ≥1%, as well as in the all-randomized population. The CheckMate-648 trial was the first global Phase III trial that evaluated the immunotherapy and chemotherapy combination and a dual immunotherapy combination in advanced esophageal squamous cell carcinoma. Also, the Opdivo+Yervoy combination was the first dual immunotherapy combination to demonstrate a superior survival benefit compared to chemotherapy in this setting. The primary endpoints of the trial, overall survival (median OS) in patients whose tumors expressed PD-L1 was 15.4 months for the Opdivo+chemotherapy group and 9.1 months for the chemotherapy group. The secondary endpoint, median OS in the all-randomized patient population, was 13.2 months and 10.7 months respectively. The Opdivo+chemotherapy combination also demonstrated a statistically significant PFS improvement in patients whose tumors expressed PD-L1. The median PFS by blinded independent central review (BICR) was 6.9 months in the Opdivo+chemotherapy group, which was longer than the 4.4 months in the chemotherapy alone group. The primary endpoint, median OS of patients whose tumors expressed PD-L1 was 13.7 months for the Opdivo+Yervoy group compared to the 9.1 months in the chemotherapy alone group. The secondary endpoint, median OS in the all-randomized patient population, was 12.8 months vs. 10.7 months, respectively. The Opdivo-Yervoy combination did not meet its other primary endpoint of PFS by BICR, recording 4.0 months and 4.4 months, respectively. The median duration of response (DoR) per BICR was 8.4 months for Opdivo+chemotherapy, 11.8 months for Opdivo+Yervoy, and 5.7 months for chemotherapy alone in patients whose tumors expressed PD-L1, and 8.2 months, 11.1 months, and 7.1 months, respectively, in the all-randomized population. Opdivo+chemotherapy also showed a clinically meaningful increase in objective response rate (ORR). The ORR per BICR was 53% for Opdivo+chemotherapy, 35% for Opdivo+Yervoy, and 20% for chemotherapy alone in patients whose tumors express PD-L1 and 47%, 28% and 27%, respectively, in the all-randomized population. Meanwhile, Opdivo as monotherapy was approved in April 2020 for patients with unresectable advanced or recurrent esophageal squamous cell carcinoma that were refractory or intolerant to fluoropyrimidine and platinum-based chemotherapy.
- Policy
- Discussions began on the scope of Mifegymiso license
- by Lee, Tak-Sun Nov 24, 2021 05:53am
- Moon Eun-hee, head of the pharmaceutical policy division at the MFDSAn expert meeting was held on the 24th, and the review was conducted regardless of the revision of the criminal law. The MFDS, which is reviewing the product license of Mifegymiso, a drug for abortion, has begun a discussion process on the specific scope of use rights. It is a policy to decide through collecting opinions from all walks of life. Moon Eun-hee, head of the pharmaceutical policy division, said on the 23rd, "We are scheduled to hold a meeting with experts on Mifegymiso screening measures on the 24th. We are thinking about whether to limit prescription authority to obstetrics and gynecology and what capabilities we will describe." She added that Mifegymiso will basically be classified as Rx drug and compare preparation and administration cases in various countries to discuss whether it will be inpatient Rx or outpatient Rx. However, she mentioned that an agreement with all walks of life is needed. She stressed that she does not conduct a permit review on the premise of revising the criminal law related to abortion, but that she hopes the law will be revised as soon as possible so that licensed products can be used. It is found to be contrary to the opinion that Mifegymiso's approval review should be delayed due to the lack of criminal law by Seo Jung-sook and others. The abortion crime was abolished in 2018 when the Constitutional Court ruled against the Constitution. At that time, the Constitutional Court recommended that supplementary legislation be completed by the end of 2020, and five bills, including related criminal laws, were submitted to the National Assembly, but have not been processed. The criminal law contains specific conditions and regulations that allow abortion. The MFDS expects that abortion drugs will not violate the revised law and plans to examine them according to scientific procedures and methods. She explained, "I don't think that the termination of pregnancy in efficacy will apply to the revised Pharmaceutical Affairs Act related to the expression of abortion suggestion." She said, "Even in the revised criminal law, drugs, including drugs, are not considered to be applied to abortion conditions and grounds, but it seems that (related drug permission) is not desirable because it varies depending on interpretation." However, as collecting opinions from all walks of life is important, she plans to continue to discuss drug use. "I don't think it will be concluded by a single meeting on the 24th," she said adding, "There has been a process of collecting opinions from all walks of life, but we will continue to receive opinions if necessary." The plan is to determine whether the method of collecting opinions will be a consultative body of experts or a larger scale such as public hearings depending on the situation. For now, it is known that expert organizations such as Korean Association of Obstructors & Gynecologists, Korean Society of Obstetrics and Technology, and Korea Society of Health System Pharmacists will attend the meeting on the 24th. Regarding Mifegymiso's Bridging Study, the Central Pharmaceutical Review Committee also had a number of opinions on the exemption of Bridging Study, but it was not finally confirmed. Currently, the Mifegymiso review has been requested to supplement the data, but the data has not been submitted yet.
- Product
- AstraZeneca vaccination is expected to end as of this year
- by Nov 24, 2021 05:53am
- The first inoculation will end at the end of November, and for the second inoculation, all inoculations will end on the 31st of next month. Medical institutions that have AstraZeneca vaccines should provide primary vaccinations with vaccines they have, and inform the inoculated that secondary vaccinations should be cross-vaccinated with Pfizer vaccines. However, if the vaccinated person want to have AZ shot, the AstraZeneca vaccine can also be vaccinated until December 31 of this year. The KDCA recently guided medical institutions entrusted with COVID-19 vaccination on the end of the AstraZeneca vaccination. Those who have already been scheduled for the second vaccination with AstraZeneca vaccine will be vaccinated according to their reservation details, but if they wish, cross-vaccination is also possible through the health center. However, those who are scheduled for the second vaccination with AstraZeneca vaccine in 2022 will be changed to cross-vaccination. The KDCA urged consigned medical institutions to cooperate to ensure safe vaccination by familiarizing themselves with the expiration date of the vaccine they have and how to inoculate them. The COVID-19 vaccination response promotion team explained, "There are no plans to introduce additional AstraZeneca vaccines, and the validity period of the previously introduced inventory is imminent, so it is necessary to review the inoculation plan considering the amount available."
- Policy
- Betmiga PR prices fluctuated 3 times Between 15 days
- by Kim, Jung-Ju Nov 24, 2021 05:53am
- It is a drug with a lot of stories. Betmiga PR (Mirabegron) of Astellas Pharmaceutical of Korea, which is in a lawsuit with the government to cancel the drug price drop, is a drug with a lot of price fluctuations. The drug has repeatedly filed lawsuits against the government's drug price cut, returning, cutting and raising drug prices as the results of the Price-Volume Agreement and additional calculations are added, with at least three drug price changes expected this month alone. In the aftermath, continued settlement and fluctuations in pharmacies and distributors are expected to follow, signaling chaos. According to the Ministry of Health and Welfare, the price of two Betmiga PR (Mirabegron) items, whose suspension of drug prices was lifted on the 14th, will rise slightly as of the 22nd as the price hike was adjusted this time. The increased price is KRW 314 for Betmiga PR and KRW 471 for 50mg of Betmiga PR. Up to two additional changes from the new generic registration to the new suspension of execution It is now common for drug price changes to occur frequently due to drug price lawsuits against the government. However, Betmiga PR is experiencing price hikes and cuts due to additional criteria, application and cancellation of the Price-Volume Agreement results, and price changes due to further litigation. Since the drug was lowered on the 14th due to the previous ruling of the administrative court (2021a 10434), the government has considered the additional application of the drug. This drug is subject to additional application. Therefore, it was raised to the 22nd by applying an additional calculation as of the standard from the 14th application at the time. In addition, the cancellation of the Price-Volume Agreement conducted earlier this year was reflected, making it different from the drug price (price before 14 days) at the time of the administrative court suit. The company is filing an appeal with the High Court. At the same time, the company raised a suspension to the effect of maintaining the actual initial price, but on the 12th, the High Court did not accept it unusually. However, since the suspension of execution can be carried out separately from the lawsuit on the merits of our law, the company immediately applied for a separate suspension of execution to the Supreme Court, and the results have not yet been released. If the Supreme Court results are decided to cite suspension of execution, the price will change again if the price changes to its original state Price fluctuations do not stop here. As Mirabegron's generic is scheduled to be additionally registered on December 1, the drug price change, which was expected to be adjusted to December 22, will change again in December. In other words, since there are three companies based on registered companies and the number of new generics exceeds three companies, the additional mechanism applied by the government will be lifted and the price will fall again. This is a change in drug prices that has progressed or is scheduled for only 15 days since the application of the administrative court results on the 14th, and the number of times alone is as many as three or up to four times. Confused by frequent fluctuations in drug prices and wholesale and retail prices of pharmacies and distribution prices As a result, the return and settlement of distributors and pharmacies, which are wholesale and retail branches of drugs, and confusion in face-to-face patients are inevitable. First of all, pharmacies should pay attention to discrepancies in claims if they miss the update of drug prices. In addition, it should be notified when facing the patient. In the case of distributors, they must make predictable plans for returns and settlements to check the volume with trading pharmacies and customers. Due to the nature of wholesale and retail dealing with tens of thousands of drugs, such confusion is expected to continue unless the system and law improve. In order to solve such a legal battle, the ruling party is currently pushing for a revision of the law aimed at banning and recovering corporate lawsuits, and the government and insurance authorities are also closely watching it. The MOHW said, "The part to be raised and adjusted as of the 22nd will end on December 1st," adding, "Astellas is appealing to the Supreme Court (related to suspension of execution), so if there is any change, additional information will be provided immediately."
- Policy
- MFDS cautious on waiving bridging trial for abortion pill
- by Choi-sun Nov 24, 2021 05:53am
- The Ministry of Food and Drug Safety, which had been accelerating the approval of the induced abortion pill Mifegymiso (misoprosto + mifepristone), has taken a step back in response to the caution urged by the National Assembly among others at the NA audit. Despite being advised to waiver the bridging study by the Central Pharmaceutical Affairs Council, the MFDS turned to take a more reserved position on the exemption of such trials. Considering the progress of the review, as Hyundai Pharm would need to prepare the supplementary data and receive another review for the submitted materials, it is predicted that it will be difficult for the company to obtain approval within this year. According to the MFDS on the 17th, the authorities requested supplementary data for Hyundai Pharm’s application on Mifegymiso but deferred providing a definite answer on whether it will exempt a bridging clinical for the drug. # A bridging study is added when it is difficult to apply foreign clinical trial results locally due to ethnic differences in evaluations. In early September, the MFDS received a recommendation to waiver the bridging trial after holding a CPAC meeting. Since the addition of a bridging trial could postpone the approval of a drug by 2 to 3 years, whether the bridging trial will be initiated was the center of focus to the company as well as women’s and academic societies. At the time, the prevailing opinion was that the MFDS would waive the bridging trial and rapidly progress the approval process in accordance with the advice from external experts. However, the ministry later changed its position, faced with opposition from the Korean College of Obstetrics & Gynecology and the concerns raised on the hasty introduction of the drug. An MFDS official said, “We are aware of the great need for relevant regulations and drugs after abortion was decriminalized. However, we are also aware of the rising concerns over its safety, which is why we need to exercise caution on the matter.” He added, “The ministry had requested Hyundai Pharm’s to submit supplementary data on the approval of Mifegymiso. We had requested supplements after consulting with external experts and conducting data review, and the company has not submitted the additional data yet.” “We have set a deadline for the supplementary data submission, however, the deadline may be extended upon the company’s request. We can only proceed further after we receive the data,” said the official. Regarding the initiation of a bridging study, the MFDS plans to reexamine the issue through further expert review. The MFDS official said, “We have already completed seeking expert advice on conducting a bridging study for Mifegymiso, but did not make a decision at the ministry level on whether to request or waiver a bridging study.” He added, “This seems to be an issue that should be reviewed after the additional data are submitted. We plan to once again review expert opinions on the matter after receiving the supplementary data.”
- Policy
- Nam In-soon's drug price recovery bill excludes rebates
- by Lee, Jeong-Hwan Nov 23, 2021 05:55am
- The "Return and refund of suspension of execution of drug prices" bill proposed by Rep. Nam In-soon of the Democratic Party of Korea varies in scope of application to benefits deletion, suspension of benefits, and drug price reduction due to revaluation of starting drugs. However, Rep. Nam In-soon's bill does not include the disposition of drug price reduction due to the detection of illegal rebates. The two bills differ in that the previously proposed Democratic Party lawmaker Kim Won-yi's bill was subject to redemption and refund of only the original patent expiration drug price and the rebate detection drug price. As Rep. Nam recently proposed an additional revision to the National Health Insurance Act, pharmaceutical companies that have conventionally applied for suspension of execution shortly after the patent expiration drug price was lowered have become more interested in the bill. The National Assembly's Health and Welfare Committee announced the subcommittee on the first bill on the 23rd and 24th. Therefore, it is not yet known whether the bill proposed by the two lawmakers will be reviewed by the end of this year. Rep. Nam's bill laid the groundwork for ex officio adjustment of the benefits, scope of benefits, and upper limit of registration drugs, as set by the Minister of Health and Welfare by Ordinance of the MOHW.(New Article 41-35) In particular, regarding the ex officio adjustment of the Minister of Health and Welfare, the NHIS specified the basis for collecting or refunding losses incurred by pharmaceutical companies filing administrative trials and administrative litigation.(New Article 101-2(1)-6) The ex officio adjustment of the Minister of Health and Welfare includes the expiration of the original patent, the registration of generics, and the deletion of benefits, suspension of benefits, and drug prices due to revaluation of registered drugs. The disposition of drug prices for drugs caught in rebates was excluded. This part is different from Kim Won-yi''s bill. In the case of exclusion or suspension of benefits, the upper limit of losses cannot exceed 40/100 of the difference in medical care benefits. The supplementary provisions stipulate the enforcement date of the bill as the day six months have elapsed since its promulgation. The revised regulations were to be applied from administrative trials or administrative litigation filed for the first time since the enforcement of the law, so that past lawsuits for drug price reduction were not retroactively applied.
- Company
- Bavencio cost support provided in non-reimbursed areas
- by Eo, Yun-Ho Nov 23, 2021 05:54am
- Pharmaceutical expense support for the cancer immunotherapy drug ‘Bavencio’ in non-reimbursed areas has begun. According to industry sources, Merck and Pfizer have started a patient support program to refund part of the expenses patients spend on Bavencio (avelumab) as first-line monotherapy for metastatic Merkel cell carcinoma and as first-line maintenance treatment for the recently approved locally advanced or metastatic urothelial carcinoma. Both companies plan to support part of the pharmaceutical expenses borne by patients who were prescribed Bavencio without reimbursement and must bear the full price. In particular, the Early Access Program (EAP) gained attention as it supports the recently approved urothelial carcinoma indication that lacks treatment options. Bavencio is an anti-PD-L1 immunotherapy that was first authorized in 2019 to treat Merkel cell carcinoma, then as a first-line maintenance therapy last August for patients with locally advanced or metastatic urothelial carcinoma who have not progressed after using platinum-based chemotherapy by the Ministry of Food and Drug Safety. The indication was approved based on the Phase III JAVELIN Bladder 100 trial that compared the outcomes between the best supportive care (BSC) and Bavencio+BSC. Study results showed the median overall survival (OS) was extended by over 7 months for patients who received Bavencio+BSC compared to BSC care alone, and the risk of death was also reduced by around 31%. Jae-lyun Lee, professor of Oncology at Seoul Asan Medical Center, said, “Urothelial carcinoma, which is the most common type of bladder cancer, accounts for around 90% of all diagnosed cases. Around 12% of patients are diagnosed at an advanced stage, and the 5-year survival rate of patients who have distant metastasis is only around 6%, showing the dire need for a suitable treatment that could treat or extend the life of these patients.” Bavencio was approved as second-line treatment for Merkel cell carcinoma in March 2019 and was first listed for reimbursement last October for the same indication.
- Company
- Myungin signed an exclusive license agreement for Parkinson
- by Nov 23, 2021 05:54am
- Myungin announced on the 22nd that it has signed a license and investment contract with Israeli pharmaceutical company Pharma Two B (P2B) for commercialization of Parkinson's disease treatment in Korea. P2B001, which is being developed by P2B, is a new combination of low-dose sustained-release drug Rasagilin and sustained-release drug Pramipexole, which is widely used for Parkinson's disease. It is manufactured to solve unmet demand while minimizing side effects by combining two drugs that act as different pharmacological mechanisms. P2B001 is taken only once a day, and dose control is not required. P2B completed multinational phase 3 clinical trials of P2B001 in 70 regions of North America and Europe. It is planning to announce the results of phase 3 top line within this year. The goal is to release the product in 2023 after applying for permission in the U.S. and Europe in the second quarter of next year. With this contract, Myungin has the right to commercialize and manufacture P2B001 exclusively in Korea. To this end, Myungin will invest $5 million (about 5.9 billion won) to make equity investments. "P2B001 has the potential to become a new treatment that combines different mechanisms for patients suffering from Parkinson's disease," said Lee Hae-myung, chairman of Myungin. "We hope that cooperation with P2B will provide necessary treatment for patients with Parkinson's disease in Korea."
- Company
- Maven Clad can be prescribed in Big 5
- by Eo, Yun-Ho Nov 23, 2021 05:54am
- Maven Clad, a new drug for multiple sclerosis, has completed its entry into the Big 5 Advanced General Hospitals. According to related industries, Merck's highly active multiple sclerosis treatment Maven Clad (Cladribine) has currently passed DC of medical institutions such as Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, AMC, and Sinchon Severance Hospital. MavenClad is the first short-term oral treatment to show overall significant effects in terms of the degree of progression of physical disability, annual recurrence rate, and number of active lesions shown in MRI (magnetic resonance imaging) tests. The efficacy of this drug was confirmed through long-term follow-up data of the 8-year prospective observational registry PREMIERE study, along with CLARITY Phase III study and CLARITY Phase II study, which corresponds to CLARITY expansion clinical trials. In a two-year CLARITY 2 and 3 study, post-analysis of patients with high disease activity showed a 67% reduction in annual recurrence rate in patients with Maven Clad, and an 82% reduction in extended disability status scale (EDSS) indicating disability progression in the Maven Clad administration group. However, lymphocytopenia and shingles can occur as significant adverse reactions when administered with Maven Clad, so patients' lymphocyte levels must be measured before and during administration of Maven Clad to patients with multiple sclerosis. Maven Clad administration is prohibited in certain groups, including patients with impaired immune function and pregnant women. Maven Clad recently released retrospective observational study data and analysis results related to COVID-19 vaccination in patients with multiple sclerosis. In the case of patients receiving immunosuppressive treatment for autoimmune diseases such as multiple sclerosis, vaccination is recommended because they are more vulnerable to COVID-19 infection and are more likely to be severely transmitted if infected. A recent independent study in Israel targeted 23 patients with recurrent dysplasia (at least 4.4 months after treatment) treated with Maven Clad. As a result of the study, all 23 patients were confirmed to have a protective IgG antibody response to the COVID-19. Dimitrios M. Karussis, a neurologist at Hebrew University in Israel, explained, "If immunity is reduced due to immunosuppressants, the immune response of the COVID-19 vaccine may decrease or affect its efficacy, so patients and medical staff were deeply concerned." In addition, he added, "This study is very encouraging data for multiple sclerosis patients and medical staff in such a situation, and it is also meaningful because no unexpected safety problems were found compared to healthy ordinary people when vaccinated with Maven Clad."
- Policy
- Brilinta’s price cut 30%, Nexavar’s premium stays 1 year
- by Kim, Jung-Ju Nov 23, 2021 05:54am
- The insurance price of AstraZeneca Korea’s Brilinta tab. 90mg (ticagrelor) and Daxas tab. 500μg (roflumilast) will be reduced by 30% through the government’s ex-officio adjustment starting next month. On the other hand, the price of Bayer Korea’s Nexavar 200mg (sorafenib tosylate) will be maintained at its level for one more year. The price of Hanlim Pharm’s Entelon, whose indications for blood circulation and ophthalmologic diseases survived the Pharmaceutical Benefit Adequacy Assessment, was voluntarily lowered by 2.6-2.9% for each dose. According to the industry, the Ministry of Health and Welfare is working to apply the ‘Amendment to the drug reimbursement list and reimbursement ceiling price table’ that contains the abovementioned changes by December 1st. First, two drug items that were newly applied premiums will end in December. The government applies a 59.5% premium or one year from the listing of the first generic. For innovative pharmaceutical companies, the premium is set at 68% of the original drug price in the first year, then subsequently lowered to 53.55% after the term is terminated. The two items subject to this form of price cuts are Handok Teva’s ‘Teva Bendamustine Inj. (bendamustine hydrochloride)’ 25mg and 100mg. The price of the two drugs will fall 10% each from coming March 1st, 2022. One product will be maintained the premium pricing status. The government allows premium pricing period extensions for drugs produced with identical ingredients by 3 or fewer companies. The product that will be subject to an extension this time is Bayer Korea’s Nexavar 200mg. Although Nexavar’s premium pricing period was set to expire, it was able to maintain its premium due to 3 or fewer companies producing drugs with identical ingredients. Therefore, Nexavar’s premium pricing will be terminated on December 1st, 2023. If the company applies for an evaluation to maintain its premium pricing, the government and HIRA would need to conduct an evaluation to determine whether to continue applying premium. If the authorities decide to terminate the term, the price falls 23.5%. The premium pricing period for Hanmi Pharmaceuticals’ Mirabeg 50mg (mirabegron) has also expired, and its price will be cut 21.3% from the first of next month. Also, the price of Astellas Korea Betmiga (mirabegron), which had been fluctuating due to the suit filed by the company to cancel the government’s price cut decision, will be reduced by 23.6% on the same day due to the premium pricing period expiry. Three items will undergo price cuts next month through ex-officio adjustments. The government makes ex-officio price adjustments to the first-listed product and the product with the same route of administration, ingredient, and formulation as the first-listed product. The three items are AstraZeneca Korea’s Brilinta tablets and Daxas tablet. The price of Brilinta 90mg will be cut by 30%, 60mg by 29.9%, and Daxas 500μg by 30%. The premium pricing period of the ex-officio price adjusted items is set to expire on November 2022. When a generic is listed for the first time, the price of the first-listed product is given a 70% premium for a year, then returned to the original level. If 3 or fewer companies sell the same product with the identical ingredient, the government allows the company to maintain the premium for up to 5 years until the number of companies becomes 4 or more. The price of Brilinta will be reduced by 23.5% for each dose from November 21st, 2022, and the price of Daxas 500μg will be reduced by 23.5% from November 1st, 2022.
