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- 2025-12-24 02:58:12
- Policy
- Clinical re-evaluation is being reviewed for Formoterol
- by Lee, Tak-Sun Nov 19, 2020 06:10am
- The MFDS is reviewing a clinical re-evaluation of Formoterol Fumarate Hydrate tablets and syrups used to treat asthma. This is because the need for validation was raised during the renewal review process. However, the policy is to finalize the re-evaluation through the Central Pharmaceutical Affairs Review Committee. According to the MFDS on the 16th, the Central Pharmaceutical Affairs Review Committee meeting will be held on the 23rd to review whether a clinical re-evaluation of Formoterol fumarate Hydrate will be conducted. Formoterol Fumarate Hydrate is primarily used for asthma. It is mainly composed of inhalants, syrup, and tablets, but the targets of this re-evaluation are syrups and tablets. It is known that inhalants occupy 90% of the market. Unlike inhalants with many imported drugs, both tablets and syrups are domestically produced drugs. Seventeen items, including Sama's Atock tablets and Atock Dry Syrup Sama, are licensed for the first time. In the case of Sama's Atock, the amount of outpatient prescriptions amounting to ₩5 billion based on UBIST last year. These drugs are currently used to relieve symptoms of bronchial asthma and bronchitis. It is known that this re-evaluation review was due to the need for validation compared to overseas during the renewal review process. However, the specific issue was not known. An official from the MFDS said, "We are reviewing clinical re-evaluation for syrups and tablets." "The final decision will be consulted and judged by the Central Pharmaceutical Affairs Review Committee." Meanwhile, in 2010, the MFDS recommended that long-acting β-agonists (LABA) such as Formoterol should not be used alone in asthma patients according to the basis of the US FDA analysis. The FDA has established these guidelines based on research findings that use alone may increase the risk of worsening severe asthma symptoms. This is reflected in the current permits.
- Policy
- The use of antibiotics in Korea is 1.6 X that of the OECD
- by Kim, Jung-Ju Nov 18, 2020 07:59am
- The use of antibiotics in Korea was 1.6 times the average of OECD member countries in 2018. Of these, inadequate prescriptions such as antibiotics for colds account for 28%, so it is important to prevent resistance. The KDCA (Director Jeong Eun-kyeong) emphasized the adherence and practice of antibiotic resistance prevention rules to overcome antibiotic resistance ('super bacteria') in celebration of World Antibiotic Resistance Awareness Week (the third week of November every year). The World Health Organization (WHO) warns that antibiotic resistance will be an immediate public health crisis for humanity, and emphasizes that efforts in a variety of fields, including human and livestock, food and environment, are essential to overcome antibiotic resistance. As of 2018, the domestic human antibiotic use (DDD/1000 persons/day) was 29.8, 1.6 times higher than the average of 25 OECD countries (18.6). The Korean government participated in international efforts to prevent antibiotic resistance and It is promoting the National Antibiotic Resistance Management Measures ('16~'20), covering the fields of the health care, agriculture and stockbreeding field, food, and the environment. As part of the 'National Antibiotic Resistance Management Measures', this week's Antibiotic Resistance Awareness Week is meaningful in driving the national countermeasures by joining the public to improve awareness and complying with the rules of practice, the Korea disease agency explained. To prevent antibiotic resistance, it is important to reduce unnecessary use of antibiotics and improve awareness of the correct use of antibiotics. In particular, in Korea, 27.7% of antibiotics are inappropriately prescribed, and antibiotics are prescribed for cold patients who do not need antibiotics (acute upper respiratory infections) (2019: 38.3%, 2018: 38.42%, 2017: 39.68%, 2016: 42.9%). According to the results of an antibiotic resistance awareness survey conducted by the KCDC in 2019, 'Antibiotics are helpful in treating colds (40.2%)', 'You can stop taking antibiotics at will (39.4%)', ' When receiving treatment for a cold, the response that “there was a request for antibiotics prescription” (13.8%) is still high, so improvement of awareness of antibiotics should be preceded. Commissioner Jeong Eun-kyeong emphasized, "It is important that not only medical personnel but also the public participate in the proper use of antibiotics and prevention of resistance to antibiotic resistance, and to observe and practice antibiotic resistance prevention rules." In addition, she said, "We will do our best to protect the national health through national efforts to prevent antibiotic resistance, such as raising public awareness and practicing, and continuously promoting national antibiotic resistance management measures." Meanwhile, the KCDA plans to produce promotional materials to help comply with and practice the rules for preventing antibiotic resistance, and publish them online through the KCDA's social channels and website (homepage).
- Policy
- Multiple myeloma treatment 'Ninlaro' passed by the committee
- by Lee, Hye-Kyung Nov 17, 2020 06:27am
- Takeda Korea's multiple myeloma treatment'Ninlaro (Ixazomib)' passed the committee's deliberation. The HIRA (President Kim Sun-min) released the results of the deliberation on the adequacy of medical care benefits at the '11th Drug Benefit Evaluation Committee in 2020' on the 13th. The new drugs that have been deliberated on the adequacy of reimbursement this time are a total of 5 items including 'Ninlaro' 2.3·3·4mg, Beovu, and Beovu PFS. Ninlaro, which passed the committee, was designated as an orphan drug in May 2017 and was approved in Korea in July. After challenging the reimbursment since 2017, it was lost, and prescriptions were made at the hospital with free supply from last year. This drug has been approved for combination therapy with Lenalidomide and Dexamethasone in patients with multiple myeloma who have received more than one treatment. Novartis Korea's neovascular (wet) age-related macular degeneration treatments, Beovu and Beovu PFS, have Benefit Adequacy, but failed to pass the committee review due to the high price submitted by the pharmaceutical company. However, if Novartis accepts less than the evaluation amount suggested by the HIRA, the deliberation will pass. Beovu and Beovu PFS received domestic approval in June and July respectively.
- Policy
- Cyramza OS Clinical 9.6 months vs. RWE 7.9 months
- by Lee, Hye-Kyung Nov 17, 2020 06:26am
- Apparently a study in South Korea comparing the clinical trial result and real world data has found a targeted therapy for stomach cancer Cyramza (ramucirumab) and a targeted therapy for breast cancer Kadcyla (trastuzumab) have shorter overall survival in the real world. The clinical trial report on Cyramza stated its overall survival (OS) reached 9.6 months (8.5-10.8), but a statistic claim billing analysis by the Health Insurance Review and Assessment Service (HIRA) found the figure to be at 7.9 months (6.3-8.4), and it marked 10.0 months (9.3-10.7) in an analysis on medical record archived by research participating hospitals. As for Kadcyla with insufficient period of monitoring, patients’ progression-free survival (PFS) was compared and found the initial clinical trial result was at 9.6 months, which was 1.6 months longer than the actual medical record analysis at 8.0 months (6.8-9.4). The said gaps between clinical trial result and real-world data (RWD) was verified in the Retrospective Study on Designing the Real-world Evidence (RWE) Platform for Improved Pharmaceutical Reimbursement Management (Principle investigator: Dr. Kim Dong-suk and Dr. Byun Ji-hye) published by HIRA on Nov. 12. HIRA selected Lilly’s Cyramza (ramucirumab) and Roche’s Kadcyla (trastuzumab) as subjects for RWD-basis outcome study to generate RWE. The research was conducted as randomized controlled trial (RCT), the same method the pharmaceutical companies have used, when listed the drugs, by collecting and analyzing medical records from 242 healthcare providers (68 hospitals) associated with Korean Cancer Study Group. ◆Cyramza: The RCT evidence used when listing for the healthcare reimbursement compared the paclitaxel single therapy against Cyramza in combination with paclitaxel, which confirmed the combination therapy’s efficacy, statistically. Based on the billing data collected from May 2018—the point of Cyramza listing—through December 2018, the fatality rate in patients with a record of Cyramza prescription, from the point of first stomach cancer diagnosis to death, was reviewed. As a result, 1,023 out of 1,419 patients have died. The median OS was approximately 240 days (7.9 months), which was shorter than 9.6 months from the original RCT. The majority of the patients, or around 55% of them, were administered with the drug four times or less, followed by the number of patients who used the drug five to six times and over 10 times. The average number of administration marked 5.3 times among all patients. Analyzing the impact of variables affecting the OS with Cox proportional hazards model, the OS was statistically better when the diagnosis was given over a year ago, administration period was over 12 weeks, the number of administration was over seven times, and when it was at tertiary hospitals. The outcome study on electronic medical record (EMR) analyzed patient survival after using Cyramza with Kaplan-Meier estimator. The study concluded the time to progression (TTP) to be at 4.2 months, PFS at 4.03 months and OS at 10.03 months. The RWE based on these RWD confirms Cyramza in combination with paclitaxel showed shorter OS, compared to the original RCT. ◆ Kadcyla: Apparently, 331 out of 1,009 patients have died among the patients who were administered with Kadcyla at least once for year since the point of listing in August 2017 through July 2018. The median OS was approximately 449 days (15 months), which was shorter than both 29.9 months (Dieras et al, 2017) and 22.7 months (Krop et al, 2017) demonstrated in the company’s RCTs. But HIRA said there is a limitation with the insufficient time of monitoring as the drug received the reimbursement only from August 2017. Even with EMR data, the PFS in patients who used Kadcyla was at 6.8 months (6.2-7.4), but again the monitoring period was too short to confirm median OS.
- Policy
- No.1 anticancer drug in Rx sales is Palonosetron & Tamoxifen
- by Lee, Hye-Kyung Nov 16, 2020 06:03am
- Based on the number of prescriptions, gastric cancer patients were prescribed 'Palonosetron' and breast cancer patients were prescribed 'Tamoxifen' the most. The HIRA released a retrospective study on preparing a platform for real-world evidence (RWE) for drug reimbursement management (Research Director Dr. Dongsuk Kim, Dr. Jihye Byun). This study explains the current status of medicines for gastric and breast cancer patients. According to the research report, the most frequent medicines for gastric cancer patients in 2018 were Palonosetron(20.3%), Oxaliplatin (20.1%), and Megestrol (18.5%), accounting for more than half of the prescription rate. .Also, from 1st to 3rd place were the same as in 2017 .Capecitabine, which was ranked 5th in 2017, ranked 4th, accounting for 17% of the prescription rate in 2018 .The fifth was Fluorouracil .The ranking changed when it was based on drug cost .In the case of gastric cancer high frequency drugs in 2018, Oxaliplatin accounted for ₩17.3 billion (22.6%) out of the total ₩76.4 billion .Ramucirumab (16%), Imatinib (14%), Tegafur (9.4%), and Trastuzumab (7.5%) were followed . Looking at the top 20 anticancer drugs used by breast cancer patients based on the number of prescriptions, Tamoxifen (23.9%) was the same as in 2016 and 2017, and Trastuzumab was 14.2% as the second highest in 2018 .Letrozole is the same as in 2017, but the prescription ratio is 13.1%, which has increased the number of claims compared to 2017 .Goserelin (9.6%) and Cyclophosphamide (9.1%) ranked 4th and 5th . In the case of drug costs for breast cancer treatment in 2018, there was a change in ranking except for Trastuzumab (25.3%), which ranked first .In August of that year, Trastuzumab emtansine was second with 9.9%, while Pertuzumab (9.7%) and Palbociclib (7.9%) ranked third and fourth .Letrozole, which was second in 2017, dropped to sixth with 6.7%, and Doxetaxel (7.8%), which was third, fell to fifth .ult of examining the drug costs by dividing the anticancer drugs into group 1 and group 2, Doxetaxel ranked first in the gastric cancer frequency in group 1 anticancer drugs in 2018, with a high drug cost with ₩831 million, followed by Leucovorin with ₩498 million .Fluorouracil and Cisplatin accounted for ₩260 million and ₩194 million respectively .In group 2 anticancer drugs, Oxaliplatin were most expensive, and Ramucirumab was second .In 2016 and 2017, TGO (tegafur+gimeracil+oteracil) and Trastuzumab, which were second and third, ranked third and fourth .The first to third anticancer drugs in the 1st group of frequent breast cancer were Goserelin, Tamoxifen, and Doxorubicn, which were the same from 2016 to 2018 .In group 2 anticancer drugs, Trastuzumab was ranked first, with 38.7% .In 2018, the total number of gastric cancer patients was 177,271, which is increasing every year, and the total number of breast cancer patients is 199,553, an increase of about 9% every year .Like the number of patients, the number of claims increased every year .In 2018, the cost of treatment was about ₩622 billion for gastric cancer and ₩962.2 billion for breast cancer, and ₩3.5 million for gastric cancer and ₩4.8 million for breast cancer were spent per patient .In terms of anticancer drug costs, gastric cancer in 2018 was ₩76.4 billion and breast cancer was ₩340 billion, up 11.5% and 30% respectively compared to 2017.
- Policy
- Detailed review for COVID-19 tx budget are insufficient
- by Lee, Jeong-Hwan Nov 16, 2020 06:02am
- The National Assembly's Health and Welfare Committee was found to have insufficient details of the detailed review of the new budget of ₩965 billion, which accounted for the largest volume of the COVID-19-related budget, before the resolution of the budget under its jurisdiction next year. Although it accounts for the highest budget among health budgets, not welfare, the specific direction of how to spend ₩965 billion on securing COVID-19 treatments and vaccines in the future has not been reviewed, so it may be mistaken as a poor review. As a result of reviewing the budget bill decided by the Special Committee on Budget and Accounts of the Welfare Committee on the 10th, the 'COVID-19 Treatment and Vaccine Acquisition' project in the General Account of the Korea Disease Control and Prevention Agency's Medical Safety and Prevention Bureau is planned to use a detailed budget. The need for the budget was pointed out by Kiyoon Kang, a member of People Power Party. He requested a new formation of ₩965 billionn in the budget for securing treatments and vaccines. The Korea Disease Control and Prevention Agency expressed its position of 'partial acceptance', saying that advanced review is necessary in consideration of the COVID-19 outbreak situation, and the preliminary subcommittee recognized the necessity in the screening and decided to organize a new program of ₩965 billion. The budget will be reviewed by the Special Committee on Budget and Accounts after going through the plenary session of the welfare committee. The problem is that although it occupies the largest portion of the health budget for next year, the specific direction of how and where to spend the future budget has not been examined. In the future, it is impossible to know the direction of the detailed budget at all, whether the budget is to be used for free vaccination by investing a budget of ₩965 billion for the national vaccination project for COVID-19 treatment and vaccines, or to support domestic and foreign pharmaceutical companies that are needed for domestic supply and demand of treatments and vaccines. In this case, even if it is judged by the Special Committee on Budget and Accounts, there is a greater possibility that the Strategy & Finance Committee will refuse to reflect the budget because it does not recognize the validity. This is because there is a low justification for accommodating the budget of around ₩1 trillion without a specific reason. A member of the Welfare Committee's Special Committee on Budget and Accounts said, "There is no way to confirm the details of the relevant budget review and future directions," adding to the question. The noticeable budget is an advanced flu vaccine cold chain system that has revealed problems in the process of preventing COVID-19 Twindemic. Democratic Party of Korea Rep. Seo Young-suk insisted on an increase of ₩300 million in the new budget for advanced cold chain systems in the MFDS budget. Since it is necessary to introduce a temperature change system for each stage of distribution and storage after exposure to the vaccine at room temperature, the opinion is to increase the 'Intelligent Cold Chain System Introduction Research Service Budget' by ₩300 million. The MFDS also announced its acceptance of the budget and has been voted for. Democratic Party of Korea, Hyun-young Shin also requested an increase of ₩100 million from the national vaccination budget for the investigation of the cold chain of vaccine distribution in the budget of the Korea Disease Control and Prevention Agency. The Korea Disease Control and Prevention Agency also plans to accept the budget to investigate the distribution and storage of vaccines that are important to the NIP. In the MOHW's budget, a new budget of ₩2.5 billion was accepted to support the development of new drugs targeting COVID-19, solve the problem of discontinued research, and support linkage to follow-up projects. The details are the ₩1.5 billion for new drug development and ₩1 billion for the drug recycling budget using the drug repositioning strategy. Ho-young Joo, Seo Jeong-sook and Paik Jong-heon , members of People Power Party requested. Democratic Party of Korea, Seong-ju Kim and Lee In-geun were voted for an increase of ₩2 billion in the budget for establishing a clinical trial support system to support rapid development of infectious disease treatments and vaccines. Seong-ju Kim, Lee In-geun, and Nam In-soon also requested an increase of ₩1.5 billion in the budget to establish the basis for advancement of clinical trials, and the detailed budget plan is to establish a clinical platform for infectious diseases, foster clinical experts, and introduce a clinical trial center. Nam In-soon also requested an increase of ₩500 million in the clinical research budget for oriental medicine standard guidelines for the creation of an oriental medicine basis and ₩500 million for the support of the establishment of a clinical infrastructure for oriental medicine from the budget for developing oriental medicine leading technology. In The MFDS budget, Democratic Party of Korea Kang Byungwon, Ko Young-in, Kim Seong-ju, Kim Won-i, Nam In-soon, Shin Hyun-young, Seo Young-suk, and People Power Party Lee Jong-seong requested an increase in the budget for strengthening clinical trial safety standards by ₩5,316 million. The budget is based on a joint review committee for integrated review of multi-center clinical trial plans, a customized clinical helper center for patients, and DSUR data evaluation management. Democratic Party of Korea Choi Hye-young and People Power Party Lee Jong-seong also requested an increase of ₩4.2 billion in budget for approval and approval from the MFDS. It is a business that operates audit personnel by using the licensing fee as an income replacement expense. Details include ₩3,040 million for expansion of the audit personnel, ₩100 million for office rental, ₩265 million for examination-related goods, and ₩795 million for examination advisory expenses. .Democratic Party of Korea Choi Hye-young requested a new budget of ₩1.45 billion to improve accessibility for people with disabilities in drug safety information .The budget is based on the development of labeling methods and standards such as Braille on pharmaceutical packaging, research on labeling systems, education and public relations, survey and evaluation, and labor costs for six personnel at the KIDS .People Power Party Bong-min Jeon asked for ₩1 billion increase in the budget to expand the promotion of the drug side effects damage relief system .It is based on the expansion of publicity such as terrestrial advertisements, radio advertisements, and outdoor media .The Korea Disease Control and Prevention Agency's budget is the largest increase in the national vaccination budget for the prevention of COVID-19 Twindemic, along with the new budget of ₩965 billion for COVID-19 treatment and vaccine acquisition .Specifically, People Power Party Kiyoon Kang, Miae Kim, Jongheon Baek, and Hoyoung Joo requested an increase in the national expansion budget for flu vaccination by ₩274.6 billion, and the Korea Disease Control and Prevention Agency made some acceptance positions .Democratic Party of Korea Kang Byungwon, Kim Seong-ju, Kim Won-i, Nam In-soon, Shin Hyun-young, Heo Jong-sik, Ko Young-in, and Lee Yong-ho ( nonpartisan representative) requested an increase of ₩80.7 billion to expand flu vaccinations for those aged 14-18 and 62-64 .Democratic Party of Korea Yeong-Seok Seo also proposed an increase in flu vaccination budget for the ages 14-18 and 62-64 to increase by ₩41.4 billion, and Chung Chun-suk by ₩17.2 billion for 14-18 years old .People Power Party Kang Ki-yoon, Kim Mi-ae, and Paik Jong-heon called for an increase of ₩246.4 billion in the budget to add 23-valent polysaccharide vaccines and 13-valent protein-conjugated vaccines to the scope of support for the pneumococcal vaccination project over the age of 65 .Democratic Party of Korea Seo Young-seok and Choi Hye-young also proposed an increase in budget of ₩7.2 billion to support 13-valent protein-coupled pneumococcal vaccine for high-risk groups among the elderly over 65 .Democratic Party of Korea Choi Hye-young and Seo Young-suk demanded an increase of ₩100.9 billion in budget for the expansion of the human papillomavirus (HPV) vaccination program for 12-year-old girls .In addition to cervical cancer, the HPV vaccine is effective for men as it has the effect of preventing anal cancer and penile cancer, and it is pointed out that men also need vaccination to prevent men from passing the virus to women .The Korea Disease Control and Prevention Agency was in a difficult position to accept because of the cost-effectiveness of expanding boys, the effect of preventing infectious diseases, and reviewing public health priorities .The Welfare Committee is expected to hold a plenary meeting on the 17th and decide on a budget under the jurisdiction for next year, which has been preliminary reviewed by the Special Committee on Budget and Accounts .The budget proposal is finalized when it passes the plenary session after the preliminary committee's review.
- Policy
- RWD is useful for shortening new drug's approval period
- by Lee, Hye-Kyung Nov 16, 2020 06:02am
- (From left) Professor Hyungki Lee & Ph.D student Yoomin JeonOpinion was raised that the use of RWD (Real Word Data) owned by The HIRA could accelerate and improve domestic drug development and new drug approval. Prof. Hyung-ki Lee and Ph.D student Yoo-min Jeon published their contributions in the HIRA Big Data Brief on the subject of 'The possibility of utilizing HIRA big data for efficient design, simulation, and pre-prediction of clinical trials.' The research team said that deriving meaningful RWE (Real Word Evidence) from high-quality RWD through appropriate analysis 1 method shortens the process of drug development as well as new drug approval, but the HIRA's RWD can be usefully used. As a result of reproducing the CAROLINA clinical trial, which compared cardiovascular safety for diabetes treatments, Professor Patorno of the UK said that the group receiving 'Linagliptin' had more cardiovascular system than the group receiving 'Glimepiride'. The risk was reduced by 9%. While it took six weeks to analyze this data, it took a pharmaceutical company eight years to obtain the results of the Carolina clinical trial, and even including the four years it took to accumulate billing data, RWE is effectively used to reduce research costs and time. It is the opinion of the research team that it can be done. In particular, the HIRA's RWD has recently been emphasized in the epidemiological evaluation of the COVID-19 disease and monitoring the efficacy and safety of drugs. The research team said, "The HIRA has released clinical data in a large-scale open source format for the first time in order to analyze COVID-19 test and medical bill data using a common data model (CDM)." It will be the basis for linking the hospital billing data with the HIRA, and by connecting the RWD possessed by the HIRA to the EMR that contains specific clinical information and test results of individual patients, the scope of domestic RWD use can be further expanded." However, in order to actually introduce the HIRA's RWD into domestic drug development and new drug approval, it suggested the need to approach short-term, mid-term, and long-term utilization plans. First of all, it provides the basis for prescription and approval of over-licensed (off-label) drugs in therapeutic orphan groups such as children, the elderly, and pregnant women with RWD previously held as a short-term plan. And they asked for help in the development process for rare disease treatments. Lastly, the HIRA's RWD is used as a prototype of a national research cohort for the implementation of precision medicine, and a long-term use plan is needed to accelerate the process of developing innovative new drugs for new targets. The research team said, "The HIRA has already revealed that it is a domestic leader in the field of RWD and RWE through the healthcare big date platform." And the research team then emphasized that "It is necessary to establish an action plan by driving the momentum of success in the initial stage, and to pursue it strategically after consulting external experts." Developed countries have been preparing guidelines and legislation to actively use RWE in regulatory decision-making for many years. The US is focusing on securing RWD and RWE after the emphasis on developing patient-specific medicines through the '21st Century Remedial Act' in 2016 and the'Regulatory Science Strategy for 2025' in the UK this year. As 'Data 3 Act' (Personal Information Protection Act, Credit Information Act, and Information and Communication Network Act) was implemented in Korea, the HIRA, the NHIS, the Korea Disease Control and Prevention Agency, and the National Cancer Center integrated health care big data. It is now possible to use pseudonymized data.
- Policy
- COVID-19 vaccine likely to be approved w/o clinical trials
- by Lee, Tak-Sun Nov 16, 2020 06:02am
- The COVID-19 vaccine candidate material, which is showing a rapid pace in commercialization, is expected to undergo bridging study after the market because clinical trials are difficult in Korea. The clinical trial is difficult because, ironically, there are few COVID-19 confirmed cases in Korea. On the 10th, Pfizer USA and BioNTech, Germany are developing a vaccine candidate for COVID-19, showing an effect of preventing viral infection in about 90% of subjects as a result of the interim clinical trial. Pfizer is undergoing phase III clinical trials with 43,538 people. This interim result is based on data that about 90% of cases occurred in the placebo group as a result of analyzing 94 confirmed cases of COVID-19 in the group receiving the COVID-19 vaccine and the group receiving the placebo. In other words, only 10% were confirmed in the COVID-19 vaccine group. The Korean quarantine authorities plan to promote domestic introduction by looking at the final clinical results while being cautious about the intermediate clinical results. However, in Korea, clinical trials prior to domestic approval seem to be practically difficult. This is because the efficacy of the vaccine can be confirmed only when the target number of confirmed patients is reached. The clinical trial of Pfizer's vaccine will also continue until 164 confirmed cases of COVID-19 are reached. It is pointed out that in Korea, where there are few confirmed cases, it is virtually difficult to proceed with a clinical trial waiting for a confirmed case to occur in the test group. Accordingly, it is known that there is a high possibility of verifying whether the vaccine is effective in Koreans through a bridging study after marketing after approval of the vaccine based on multinational clinical trials. A bridging study refers to a test conducted for Koreans when it is difficult to apply foreign clinical data due to racial differences. To date, there has been no case of an overseas vaccine for COVID-19 applied for permission to the MFDS. However, the MFDS believes that the COVID-19 vaccine jointly developed by AstraZeneca and Oxford University will apply for approval soon, and is undergoing preliminary evaluation. Preliminary screening is conducted by the MFDS’ exclusive review team 90 days before the expected date of application for products that are expected to apply for permission. The Pfizer vaccine is also expected to undergo preliminary screening and approval early.
- Policy
- The introduction of vaccine will be discussed after results
- by Lee, Tak-Sun Nov 12, 2020 06:28am
- The MFDS said it would discuss the final clinical results of Pfizer's COVID-19 vaccine, which showed the potential for clinical success, for introduction. Seo Kyung-won, the head of the drug review department at the MFDS, made such a statement at a briefing on the approval status of vaccines for the treatment of COVID-19 held on the 10th. She said, “According to Pfizer's announcement, the interim results of a phase III vaccine trial resulted in 94 infected patients with 38,599 vaccines twice on the 8th.” She also reported that the vaccinated group had more than 90% of the preventive effect when compared to the non-vaccinated group. "Intermediate results seem positive, and phase III trials are currently in progress in six countries including the US and Brazil," she added. The phase III clinical trial ends when 164 confirmed cases are found. She said, “We will comprehensively judge the final clinical results and determine whether it is effective or not, such as safety, duration of immunity, and effects on the elderly.” “We have been continuously monitoring the test results, but we will continue to closely monitor the test results, and we plan to discuss the introduction at the government level.”
- Policy
- Boryung introduced Symbenda's first generic in Korea
- by Lee, Tak-Sun Nov 12, 2020 06:19am
- #Boryung introduces a generic drug which was reimbursed in 2 years ago. Boryung's Bendamustine HCl is the first generic for Symbenda. The MFDS approved Boryung's Bendamustine HCl on the 11th. It is a generic for Symbenda which was approved by Ezai Korea in 2011, and is the first generic in Korea. Symbenda was approved in 2011, but it took seven years to be reimbursed. It has been listed in September 2018. BR (Bendamustine/Mabthera (Rituximab)) therapy was successfully applied in Follicular Lymphoma (FL) with no previous treatment experience, raising expectations. BR therapy is recommended as a first-line treatment for follicular lymphoma patients in the United States and Europe. Follicular Lymphoma accounts for about 3% of all non-Hodgkin lymphomas, an average of 150 patients a year, and most of them are 55-60 years old. BR therapy demonstrated the efficacy of improving overall health status and improving quality of life in terms of cognitive, emotional, and social function in a phase III study compared with standard therapy R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin HCl, Vincristine Sulfate, and Prednisolone). .The safety aspect is improved compared to the existing Mabthera-based chemotherapy combination therapy .Last year, Symbenda recorded sales of ₩2.5 billion (IQVIA) in Korea .Symbenda's re-examination (PMS) expired on June 16th .As there are no patents listed on the MFDS’ Green List, there are no restrictions for generics to enter .Boryung, which has established a strong sales network among domestic companies in the anticancer drug market, preoccupied the first generics .Boryung is also developing 'BR2002', a new drug for treating non-Hodgkin's lymphoma .BR2002 was approved for phase I clinical trial by the US FDA last year .It has 4 licensed lymphoma treatment systems .Boryung's 'Bendamustine HCl', which was approved this time, is an imported finished drug by Boryung .
