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- 2025-12-23 19:20:19
- Policy
- Multidrug-resistant ‘Zavicefta’ applies for approval
- by Lee, Hye-Kyung Mar 29, 2022 05:54am
- Pfizer Korea has applied for the approval of its important treatment for severe gram-negative bacterial infection, ‘Zavicefta.’ Zavicefta, which received marketing authorization in 2016. is a combination drug that contains the third-generation ceftazidime. According to industry officials on the 28th, Pfizer Korea recently submitted an application for the marketing authorization of Zavicefta to the Ministry of Food and Drug Safety. Zavicefta was developed to address the urgent need for new antibiotics in severe infections that cause serious problems such as multidrug-resistant pseudomonas aeruginosa or carbapenem-resistant gram-negative Enterobacteriaceae and extended-spectrum-lactamase (ESBL) producing intestinal bacteria. Zavicefta is used for the treatment of adult patients suffering from complicated intra-abdominal infections (cIAI); complicated urinary tract infections (cUTI), including pyelonephritis; hospital-acquired pneumonia (HAP); and the treatment of aerobic Gram-negative infections in adult patients who have limited treatment options. Zavicefta was developed by AstraZeneca. On August 24th, 2016, the company sold the global development and sales rights for its low molecular weight antibiotic business outside the United States to Pfizer.
- Policy
- Will the migraine tx Reyvow step on the same track
- by Lee, Tak-Sun Mar 29, 2022 05:54am
- IldongIldong Pharmaceutical's domestic copyrighted migraine drug Lasmiditan seems to be speeding up its benefit using the patent-approval linkage system. According to the industry on the 28th, the HIRA is recently listening to opinions on whether the migraine treatment Reyvow 50 & Reyvow100mg is eligible for medical care benefits through related conferences. Reyvow is known as the brand name of Lasmiditan, which Ildong Pharmaceutical secured domestic copyright in 2013. The group signed a development partnership and a domestic sales license agreement with CoLucid of the United States, the original developer of the drug. In 2017, CoLucid was acquired by global pharmaceutical company Eli Lilly also holds Lasmiditan's global rights. Reyvow was approved by the U.S. FDA in October 2019, and then Ildong started a bridging study for domestic permits. In January, the MFDS was found to have ended Reyvow's safety and effectiveness review. As a result, it is understood that the screening is underway using the patent-approval linkage system. It is a system that allows the MFDS to apply for a benefit decision before marketing approval based on this data when safety and validity screening are completed. Usually, it is applied after approval from the MFDS, but using the patent-approval linkage system can shorten the evaluation period by 30 to 60 days. Ildong plans to sell Reyvow domestically this year. Reyvow is the first migraine treatment to act on serotonin (5-HT) 1F receptors and has a mechanism to lower neuropeptide release and inhibit pain delivery pathways, including trigeminal nerves. It acts selectively on serotonin receptors and is characterized by no cardiovascular side effects due to vasoconstriction.
- Policy
- BMS acute myeloid leukemia tx Onureg was approved
- by Lee, Hye-Kyung Mar 29, 2022 05:54am
- Onureg 200mg and Onureg 300mg, the first PO drugs were approved. Currently, Azacitidine-based AML treatments, which are approved in Korea, are injections with Celgene's Vidaza100mg, Boryung Pharmaceutical's Vizadakin and Samyang Holdings' Azalid 100mg and Azalid 150mg, and Onureg has become the first oral treatment. The MFDS (Director Kim Kang-rip) recently approved BMS' AML treatment Onureg (Azacitidine). Onureg is an oral drug with a pink oval film coating and has the advantage of being administered regardless of meals. Indications can be used to achieve CR or CRi with incomplete hematological recovery after induction therapy, regardless of whether or not publicly announced therapy is performed, and to maintain therapy in adult patients with acute myeloid leukemia who are not suitable for HSCT. To administer Onureg, it must be initiated and monitored by a physician who has experience in chemotherapy, and should not be used interchangeably with injectable Azacitidine due to different exposure, dose, and administration schedules. Meanwhile, Onureg has been in the process of licensing items in Korea since the U.S. FDA approved in 2020.
- Policy
- Will the separation of the Ministry of Health be promoted?
- by Lee, Jeong-Hwan Mar 28, 2022 06:10am
- Yoon Seok-yeol's presidential transition committee seems to be discussing the necessity of separating the Ministry of Health and integrating and absorbing the MFDS in the process of discussing the reorganization of the government after the inauguration of the next government. As the pandemic era became commonplace due to COVID-19, the role of the health sector grew, and the medical community strongly urged the independence of the Ministry of Health and even academia insisted on the necessity of the Ministry of Health. According to Yoon Seok-yeol's transition committee and related academia on the 27th, various discussions are taking place over the next government organization, including the reorganization of the MOHW. Yoon's transition committee receives reports from each government department until the 29th, while keeping in mind the need for independence of the Ministry of Health along with the abolition of the Ministry of Gender Equality and Family. Some say that if the Ministry of Health becomes independent, the MFDS will also inevitably change its organization. With the independence of the Ministry of Health, there is a possibility that the MFDS will be integrated and absorbed as it was an organization under the MOHW in the past. If the Ministry of Health becomes independent from the MOHW, the number of personnel is about 400, and the MFDS should be integrated to strengthen and exist the ministry functions. In addition, the Ministry of Health may divide areas other than the food sector within the MFDS after independence from the Ministry of Health as there is a need to transfer food sector work within the MFDS. The medical community strongly agrees with the independence of the Ministry of Health. The Ministry of Health should be separated to respond to the public health crisis caused by the outbreak of infectious diseases and foster the health care sector. The KMA proposed several government reorganization plans to establish the Ministry of Health and manage the KDCA, the MFDS, and public health centers since Yoon was a presidential candidate. Independence of the Ministry of Health is also emphasizing the necessity of related academia. Kim Eun-joo, a professor of social science at Hansung University, appealed the need for independence from the Ministry of Health at a seminar hosted by the KAOS and the KAPAR21 on the 25th. Professor Kim Eun-joo said, "The MOHW should separate health functions and deploy the KDCA as a member of the Ministry of Health to strengthen the health and safety system based on expertise in the health sector." She said, "We need to establish an effective response system to infectious diseases such as COVID-19. The MFDS should also strengthen its health risk factor management function," she argued. Professor Kim argues that the MOHW should be divided into the Ministry of Health and that KDCA, the ministry in charge of quarantine, should be assigned as a member of the Ministry of Health. Kim Yoon-kwon, a senior researcher at KIPA, also mentioned the establishment of the new Ministry of Health, saying, "We need to redesign welfare and health functions to secure function completeness based on our expertise." The transition committee plans to collect expert opinions on independence of the Ministry of Health, reorganization of the KDCA, and integration of the MFDS. The plan to reorganize the government is expected to be outlined only after the transition committee's business report is completed and before the next government is launched.
- Policy
- Govn’t to introduce 460,000 courses of oral COVID-19 drugs
- by Kim, Jung-Ju Mar 28, 2022 06:10am
- Ki-il Lee, the first supervisor of the Central Disaster and Safety Countermeasures Headquarters The government will be introducing 460,000 courses of oral COVID-19 treatments by the end of next month. In principle, Paxlovid will be prescribed first, and Lagevrio, which has recently been approved for emergency use, should be used for patients who are restricted from using Paxlovid, such as users of contraindicated drugs. On the 25th, COVID-19 Central Disaster and Safety Countermeasures Headquarters (Head, Prime Minister Boo-kyum Kim) presided over a meeting in the videoconference room at the Sejong Government Complex with the central government departments, 17 metropolitan governments, and 18 cities and provinces on their COVID-19 vaccine/treatment development status and measures for support. According to Ki-il Lee, the first supervisor of the Central Disaster and Safety Countermeasures Headquarters who spoke at a briefing by the disease control and management authorities, the government has procured a total of 1,400,000 courses oral COVID-19 treatments and is in the process of introducing them sequentially. As of the 24th, 163,000 courses of Paxlovid (from Pfizer) have been introduced to Korea, 114,000 courses of which have been used on patients in Korea. On the criticism that Paxlovid is not being actively prescribed by managing medical institutions even if symptoms appear unless older adults in their 60s directly ask for prescriptions themselves, the authorities said they will check on it. Ki-il Lee said, “We will do our best to make sure that institutions that conduct rapid antigen testings can immediately prescribe the drugs to those aged 60 years or older and the immunocompromised. We have requested this from the presidents of 16 doctors’ associations in 16 cities and provinces. W We will do our best to allow prescriptions to be made as soon as possible." Also, the government is continuing negotiations to rapidly introduce oral COVID-19 treatments. Including the 20,000 courses introduced yesterday, the government is pushing for the early introduction of 460,000 courses of oral COVID-19 treatments by the end of April. On the 24th, the first 20,000 courses of Lagevrio were introduced in advance for use from tomorrow (26th). Lagevrio was granted Emergency Use Approval on the 23rd by the Ministry of Food and Drug Safety after conducting safety/efficacy reviews and expert consultations. In consideration of its EUA indication, the drug will be used ▲within 5 days of symptom onset, ▲on patients over the age of 60 or age of 40 with underlying diseases or immunocompromised ▲who have difficulty using existing treatments. The authorities will allow use of Lagevrio in patients who have difficulty using other treatments due to the use of contraindicating medications, etc., although Paxlovid will be first prescribed in principle. Patients with severe hepatic or renal impairment or patients taking drugs of specific ingredients (28 types (23 types that are approved in Korea)) are restricted from the use of Lagevrio. In addition, pregnant women and patients under the age of 18 are excluded from eligible subjects in consideration of the EUA condition set by the MFDS. The government said it is making every effort to ensure that the new oral COVID-19 treatment, Lagevrio, can be safely used in the field. In order to prevent prescriptions from being made to pregnant women, children, and adolescents and its safe use, the drug was registered in the DUR (Drug Utilization Review) system, and relevant systemic improvement measures were completed, such as adding drug information to the patient management information system. Also, the 'Treatment Use Guide (6th edition)' has been distributed to medical institutions to guide Lagevrio prescriptions in institutions, and pharmacies will be distributing detailed medication guides to those patients who have been prescribed Lagevrio. Meanwhile, the government announced that it would monitor the introduction and use of oral COVID-19 drugs, and will continue to compensate for serious adverse events that arise by applying the drug’s side effect damage relief procedures. The current side effects damage relief measures include a lump-sum death compensation (114 million won), funeral expenses (9.8 million won), disability lump-sum compensation (29 million won to 114 million won), and hospitalization & treatment expenses (up to 20 million won). Medical institutions, pharmacies, patients, etc. can report side effects that occur after the use of drugs to the Korea Institute of Drug Safety and Risk Management (report online at www.drugsafe.or.kr) or receive related consultations.
- Policy
- The gov's all-out efforts to promote EUA for overseas drugs
- by Lee, Jeong-Hwan Mar 28, 2022 06:10am
- The government will make all-out efforts to expand the total amount of supply by expanding the production and import of regular medicines such as antipyretic painkillers and cold medicines used to alleviate COVID-19 symptoms. It will even review the emergency introduction of foreign drugs with the same composition as domestic licensed items, quickly review them to prevent disruptions in production due to administrative procedures such as permits, and continue administrative support. The government expressed its willingness to make active efforts with the pharmaceutical industry to stabilize the supply of COVID-19, while also asking the medical and pharmaceutical sectors for cooperation such as prescribing an appropriate amount of solid drugs instead of syrup. Park Hyang, head of the Central Disaster and Safety Countermeasures Headquarters, made the announcement at a regular briefing on the 23rd. As a result of receiving a report from the MFDS on the supply and demand status and action plans for COVID-19, the Central Disaster and Safety Countermeasures Headquarters decided that supply needs to be stabilized. The shortage of some products of antipyretic pain relievers and cold medicines used to alleviate COVID-19 symptoms continues. Accordingly, the government will expand the total supply of COVID-19 medicines. Specifically, it expands production and imports and encourages rapid shipment. It will consider promoting the emergency introduction of overseas drugs with the same composition as domestic licensed products. The government plans to do its best to prevent disruptions in production by providing support for rapid processing such as changing the raw materials and manufacturing plants of standing medicines, quick import approval of drugs and raw materials contained in cold medicines, and convenience of other administrative procedures. It also asked the medical and pharmaceutical sectors to prescribe an appropriate amount of prescription and a solid drug rather than a syrup drug. The government announced its intention to maintain and strengthen support for clinical trials of COVID-19 vaccines and treatments. Currently, eight vaccine companies and 17 treatment companies (18 candidate substances) are conducting clinical trials in Korea. SK Bioscience vaccine has completed recruiting and inoculating phase 3 clinical participants with the aim of completing development in the first half of this year. Subsequently, the procedure for confirming the efficacy of the vaccine through sample analysis is in progress. The treatment is developing an additional antibody treatment (Celltrion) that can respond to mutant viruses, and Ildong Pharmaceutical is jointly conducting clinical trials by securing domestic copyright for Shionogi's developed and edible treatments. The government announced that it is supporting the development of domestic COVID-19 vaccines and treatments with all its might by operating the pan-government support committee for the development of COVID-19 treatments and vaccines. The government said, "For the rapid development of treatments and vaccines, clinical trials are more important than anything else," adding, "We ask the public to actively pay attention to and participate in clinical trials."
- Policy
- Kymriah's benefit standard has been established
- by Lee, Tak-Sun Mar 25, 2022 05:48am
- The worldChimeric antigen receptor-T cell therapy, which can be effective only once by using cancer patient T cells, is expected to be given to patients after receiving health insurance benefits for the first time in Korea from April. Novartis' Kymriah will enter the benefit range a year after being approved in Korea. The HIRA announced that it will conduct an inquiry on the "Amendment of Public Notice according to Drugs Prescribed and Prescribed to Cancer Patients" from the 24th to the 30th, including the establishment of Kymriah's standards. The amendment will take effect on April 1 unless there is a disagreement. In this amendment, standard was established to allow Kymriah to be administered to an adult (DLBCL) Diffuse Large B-cell Lympoma and B-cell acute lympneumonia (ALL), one of the non-Hodgkin lymphoma. Specifically, after two or more systemic treatments, it is newly established as a tertiary or more monotherapy for DLBCLs in adults who are recurrent or refractory. The recognition period is once in a lifetime per patient, and should be administered by a doctor with sufficient knowledge and experience in chemotherapy at medical institutions capable of responding to emergencies in preparation for unexpected side effects of CAR-T cell therapy. There was a condition that data on the status of medical care benefits should be submitted to the director of the HIRA. Accordingly, a form related to follow-up management should be submitted to the director of the HIRA at the time of administration of Kymriah, 6 months after administration, and 12 months after administration. It is also recognized if Kymriah is administered in post-transplantation recurrence or secondary recurrence and subsequent recurrence or refractory B-cell acute lymphatic leukemia (ALL) treatment in children and young adults under the age of 25. The administration stage should be secondary or tertiary or higher. It can also be administered under the direction of a medical institution suitable for treatment and an educated doctor, and the recognition period is once in a lifetime per patient. Kymriah is the world's first approved CAR-T treatment. CAR-T treatment is an immune cell therapy anticancer drug made by combining genetic information that expresses chimeric antigen receptors specific to cancer cells in patients' T cells. It is in the spotlight as a next-generation anticancer drug that can have a high effect with just one administration. However, insurance authorities have been agonizing over the difficulty of accessing patients due to high costs. Kymriah passed Drug Benefit Evaluation Committee of the HIRA in January and has been negotiating drug prices with the NHIS. Roche's Rozlytrek (Entrectinib), and Bayer's Vitrakvi (Larotrectinib Surfate) also included a new standard. Rozlytrek is newly established as a primary treatment for solid cancer in adults and children over 12 years of age with neurotic tyrosine receptor kinase (NTRK) gene fusion without known acquisition-resistant mutations. Vitrakvi is similar. However, there is no age limit for children. Non-Hodgkin lymphoma combination therapy (secondary or higher) of Rituximab+Revlimid and combination therapy of Bortezomib +Revlimid + Dexamethasone for newly diagnosed for multiple myeloma is newly established for multiple myeloma.
- Policy
- Yoon’s transition team prepares for digital platform govnt
- by Lee, Jeong-Hwan Mar 25, 2022 05:48am
- President-elect Suk-Yeol Yoon’s presidential transition committee announced a policy with the state-led public prescription system in mind. In the process of announcing the creation of a task force (TF) to bring the digital platform government into reality, the committee made a remark that it would be possible that the TF will establish a one-stop hospital treatment and prescription to pharmacy dispensing system. In the transition committee’s press conference that was held at Samcheong-dong, Seoul on the 23rd, the committee announced the creation of a Digital Platform task force (TF). The digital platform government was Yoon’s administration’s pledge to improve administrative efficiency by expanding cooperation between ministries as a state administration system that focuses on digital transformation, artificial intelligence (AI), and big data utilization. The committee’s goal is to ultimately reduce and simplify the steps in the administrative service through data integration by fully disclosing and linking public data owned by government ministries, in principle. The committee said that a site that allows a one-stop, paperless process from hospital treatment and prescription to dispensing in pharmacies needs to be prepared as one case of the digital platform government. This was a statement that can directly affect the establishment of the government-led public prescription system. The Korean Pharmaceutical Association had proposed the establishment of a public prescription issuance system to policy head Hee-Ryoung Won and the healthcare policy promotion director Jeong-Sook Seo during a policy roundtable that was held with Yoon’s policy coordination team last month. Il-Hee Won, senior deputy spokesperson of the transition committee, said, “the TF will consist of 10 members, with the Planning and Coordination Division holding the key and the Science and Technology Education Division and the Political Affairs and Judicial Administration Division working together with private ICT experts. The data is ultimately the public’s asset, therefore it needs to be given back to the people.” Deputy spokesperson Won added, “For example, you now need to receive treatment at a hospital and submit prescriptions to a pharmacy to receive medication. In order for this to become a paperless process, data must be shared, linked, and integrated. We are planning to establish a one-stop, one-site service so that these documents can be issued online." In addition, he said, “If the current government’s system ended at linking the ministries together, the digital platform government pursued by the new government will achieve integration of the ministries We will remove the barriers between ministries and open and release the data to the public, the rightful owners of the data.”
- Policy
- Corona tx Largevrio has been urgently approved
- by Lee, Hye-Kyung Mar 24, 2022 05:54am
- The MFDS (Director Kim Kang-rip) announced on the 23rd that it has decided on the EUA of Largevrio developed by Merck and imported by MSD Korea. Largevrio can be used in patients with severe liver and kidney disorders who are difficult to use injection-type treatments, and patients who cannot take Paxlovid, a conventional PO treatment, for taking certain ingredient drugs. Largevrio, which is inserted instead of RNA in the process of replicating the COVID-19 virus as an RNA-like substance, can be taken twice (every 12 hours) for five days, 800 mg (200 mg x 4 capsules) a day. It should be administered as soon as possible within five days after being diagnosed positive for COVID-19, and mild symptoms with a high risk of developing severe corona due to age and underlying diseases. It targets adult patients with moderate symptoms. Pregnant women or children and adolescents under the age of 18 are prohibited from taking them. On November 17 last year, the KDCA requested Lagevrio's EUA to the MFDS, and the MFDS decided after deliberation by the Public Health Crisis Response Medical Product Safety and Supply Committee. As a result of consultation with external experts (11 people) in various fields such as infectious medicine, toxicology, and virology, it was agreed that the need for emergency use approval of Lagevrio was recognized considering the results of non-clinical and clinical tests and the COVID-19 pandemic in Korea. Considering the results of reviewing animal test data and clinical test data, it was recommended to partially restrict the target patient group, such as not administering it to pregnant women and children and adolescents under the age of 18. The Public Health Crisis Response Medical Product Safety and Supply Committee also acknowledged the validity of emergency use approval by comprehensively considering expert advice, the increase in COVID-19 confirmed patients in Korea, access to treatment for patients who cannot use existing treatments, and medical staff's options. The MFDS will strengthen the collection of side effect information and additional safety use measures in the process of using Largevrio. It has established a system that allows domestic importers to actively collect and report domestic and foreign safety information, and allows medical experts and patients (family members) to report side effects over the phone or online.The government will continue to analyze and evaluate domestic and foreign safety information to promptly take necessary safety measures such as guidance, suspension of use, and recovery of serious side effects, and to evaluate causality and compensate for them. Side effects that occurred after using Lagevrio can be reported to drugsafe.or.kr, and side effects can be reported directly by phone (1644-6223) or related consultations can be made. It is a DUR used by medical experts for prescription and preparation that it cannot be used for pregnant women and children and adolescents under the age of 18, and plans to provide cautionary information on women, men and lactating women planning to get pregnant. In cooperation with the MOHW, the KDCA, and the Korean Pharmaceutical Association, guide patients (guardians) using Largevrio for safe use will be provided, and thoroughly managed not to be prescribed and administered to excluded patients, such as pregnant women and children and adolescents under 18.
- Policy
- Ahn to tap on “domestic production of Paxlovid generic”
- by Lee, Jeong-Hwan Mar 24, 2022 05:54am
- Transition Committee Chair Cheol-Soo Ahn (Source: National Assembly Picture Corp) President-elect Suk-Yeol Yoon’s transition committee is pursuing the manufacture of a generic version of the oral COVID-19 treatment, Paxlovid. The government plans to ask Pfizer whether it would be possible to produce generic copies of Paxlovid in exchange for royalties. At a press conference of the transition team that was held in Samcheong-dong Seoul on the 22nd, transition committee chair Cheol-Soo Ahn said, “Although it is unprecedented, there is a need to review the possibility of domestically manufacturing generic COVID-19 pills by making a deal with pharmaceutical companies for their patents in exchange for a royalty." Such a decision is interpreted as one of the changes that Chairman Ahn is preparing after criticizing the current government's COVID-19 measures as political and announcing policy reorganization for scientific quarantine at a meeting of the Special Committee for the Emergency Response to COVID-19 the day before (21st). Ahn said, “We are experiencing a severe shortage of Paxlovid and other oral COVID-19 treatments, and may completely run out of stock by April. So we need to do our best to secure oral pills to minimize those who die due to lack of treatments.” Ahn also announced his idea of conducting a public survey to investigate the rate of positive antibodies in the general public. Ahn said, “Although the confirmed cases amount to 300,000 cases a day, we estimate that the actual number of those infected is around twice that due to those who are unaware of their condition or uncounted for in the statistics. If we regularly investigate the positive rates among the general public, we can better grasp how much of the public was infected and is recovering, based on which we can establish a more accurate quarantine policy by age and region.” Regarding vaccinations and the vaccine pass system, Ahn believes it is appropriate to maintain the current measures as is, and that it is reasonable to allow people to decide upon themselves to receive vaccinations Ahn said, “although vaccinations are not mandatory even now, we all saw consensus on the fact that it should be left to the decision of individuals and parents. Some have also discussed the use of vaccine passes, but the passes have already been discontinued by the present administration, and we believe it is no longer necessary.” Meanwhile, Ahn presented 7 recommendations regarding the COVID-19 response to the government that included: ▲ Face-to-face treatment at local clinics ▲ Fast track treatment of high-risk confirmed patients ▲ Transparent disclosure of vaccine’s side effects and confirmed patient data ▲ Voluntary vaccination for 5-11 years old ▲ Procurement of oral COVID-19 treatments ▲ Extension of small business loans and deferment.
