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- 2025-12-23 15:45:15
- Policy
- Evusheld granted emergency use for preventing COVID-19
- by Lee, Hye-Kyung Jul 01, 2022 05:50am
- With the emergency use authorization has been granted for ‘Evusheld Inj,’ the first-ever preventive antibody therapy for COVID-19 in Korea, the drug is expected to be used in immunocompromised patients who are unlikely to mount an adequate response to COVID-19 vaccinations. The Ministry of Food and Drug Safety (Minister: Yu-Kyoung Oh) announced on the 30th that the ministry decided to grant emergency use authorization for 20,000 courses of the antibody therapy ‘Evusheld Inj (tixagevimab, cilgavimab) that was developed by AstraZeneca to prevent COVID-19 infections. The authorization was made after deliberation by the Medical Product Safety Management and Supply Committee for Public Health Emergency Response in comprehensive consideration of its need in immunocompromised patients that are unlikely to mount an adequate response to COVID-19 vaccinations, the MFDS’s safety, efficacy, and quality review results, and results from the expert advisory meeting. The Evusheld that received EUA today will become the first-ever antibody therapy authorized in Korea for COVID-19 prevention and is expected to contribute to the prevention of COVID-19 infections in blood cancer patients who may not mount an adequate immune response to COVID-19 vaccinations, as well as patients receiving immunosuppressant therapy after organ transplantation, etc. Evusheld has been granted emergency use authorization (EUA) in the US in December last year, then granted marketing authorization in Europe in March this year. Evusheld is a neutralizing antibody combination that binds to the spike protein of SARS-CoV-2 to inhibit virus penetration into bodies. Evusheld is approved for use in adults and adolescents (aged 12 and older who weigh 40kg or more) with moderate to severe immune compromise due to blood cancer, or immunosuppressive therapy after organ transplant that may not mount an adequate immune response to COVID-19 vaccination that are not currently infected with or had recent known exposure to a person infected with SARS-CoV-2. Evusheld is administered as an IM dose of tixagevimab (150㎎) and cilgavimab (150㎎) in two separate, consecutive injections. The emergency use authorization is a system that allows manufacturers and importers to supply unauthorized medical products in Korea to respond to a public health crisis. The Korea Disease Control and Prevention Agency requested for the EU A of Evusheld Inj. To the Ministry of Food and Drug Safety on June 10th this year. After the EUA, the MFDS will additionally make safety measures and collect information on adverse events arising from Evusheld’s use. The ministry also ordered its domestic importer to actively collect and report on its safety information in Korea and abroad, and established a system so that healthcare professionals and patients (and patient families) can report adverse events by phone or online. The ministry will continuously analyze and assess the safety information in Korea and abroad to promptly take safety measures when necessary.
- Policy
- Follow-up of impurity inspection
- by Lee, Hye-Kyung Jul 01, 2022 05:49am
- The MFDS received the results of testing and testing of Nitrosamine impurities from domestic pharmaceutical companies, and prepared safety management guidelines as a follow-up measure. This guideline is for safety management of N-Nitrosamines, a mutagenic and carcinogenic impurity among drugs, and it should be implemented by raw and finished drug manufacturers and importers to reduce or prevent impurities within the daily intake allowance. Starting with high blood pressure medicine (Valsartan) in 2018, tuberculosis medicine (Rifampicin) in 2021 as Nitrosamines were detected in drugs every year until Rifampicin), and new mutagenic impurities were recently detected, the MFDS received a test report of the company's own test on the evaluation items that may occur until the 31st of last month. The MFDS will continue to review impurities that may be included in medicines through close cooperation with overseas regulators and recommend appropriate measures to related pharmaceutical companies. According to the guidelines, apart from the MFDS' review of impurities, pharmaceutical companies should closely examine the raw material drug synthesis process and the manufacturing process of finished drugs using currently available science and technology to evaluate the potential cause and possibility of impurity generation. Pharmaceutical companies should check all impurities that may occur in the process of synthesizing and storing raw materials, manufacturing and storing finished drugs, evaluate the mutagenicity of the impurities, and if mutagenicity or carcinogenicity is confirmed, the risk of carcinogenesis is less than 1/100,000. (Q)SAR methods can be used to predict bacterial mutagenicity test results using a computer, appropriate management methods can be applied based on structural warnings, or bacterial mutagenicity tests can be conducted directly for specific impurities Nitrosamines impurities are compounds with potential carcinogenicity or mutagenicity that can occur mainly when they are combined under conditions where Amine and Nitrosating agent can react. The causes of Nitrosamines impurities in drugs identified so far can be classified as risk factors related to the manufacture and storage of raw and finished drugs, and there are also risk factors related to GMP. When detecting impurities, pharmaceutical companies should report data on the possibility of occurrence to the MFDS, the cause of occurrence (including the estimated cause), the detection amount, and the daily intake allowance. According to the step-by-step measures prepared and distributed by the MFDS, pharmaceutical companies should compare the amount of impurity detection and acceptance criteria, take necessary measures such as voluntary recovery and reduction of impurities in the market, and submit related matters to the MFDS. It will review necessary measures based on information collected from pharmaceutical companies' reporting of impurity detection and overseas regulatory agencies. If it is deemed necessary for the safety management of drugs in circulation in Korea, it is planned to instruct to evaluate the possibility of impurities and conduct test tests on specific drugs.
- Policy
- Opdivo succeeded in setting the standard as the first treatm
- by Lee, Tak-Sun Jul 01, 2022 05:49am
- Ono's Opdivo succeeded in setting the benefit standard as the first treatment for gastric cancer for the first time as an immuno-cancer drug. The HIRA held its sixth meeting in 2022 on the 29th and set the standard for the efficacy of Opdivo's primary treatment for gastric cancer. This is the first time that immuno-cancer drugs have passed the deliberation committee as the first treatment for gastric cancer patients. The deliberation committee established a combination of Opdivo's Fluorouracil system and platinum-based chemotherapy as the primary treatment for progressive or metastatic gastric cancer, gastroesophageal junction adenocarcinoma, or esophageal adenocarcinoma. However, the standard was not established for combination therapy with Ipilimumab as the primary treatment in adult patients with dermatoma among malignant pleural patients who cannot be operated, which is another indication of Opdivo. On this day, Celgene's Revlimid also succeeded in setting the benefit standard for maintenance therapy for patients who received newly diagnosed autologous hematopoietic stem cell transplants among multiple myeloma. Imbruvica and Glivec Film Coated Tab, which started to expand the benefit standard, failed to set the standard. Janssen's Rybrevant and BMS Korea's Inrebic, which newly applied for benefits, failed to set the standards, making it necessary to try again.
- Policy
- SKY Covione is promoted the registration of the WHO EUL
- by Lee, Hye-Kyung Jul 01, 2022 05:49am
- SKY Covione, a COVID-19 vaccine developed in Korea and approved, is conducting a rolling review to promote the registration of the WHO Emergency Use List (EUL) and to go through the European EMA approval process. The MFDS (Director Oh Yoo-kyung) held a briefing at 2 p.m. today (29th) and announced that it decided to approve the product on June 29th on the condition that SK Bioscience submitted a final clinical trial report for COVID-19 vaccine SKY Covione. At the briefing, Park In-sook, head of the bio-drug review department at the National Institute of Food and Drug Safety Evaluation, explained the future commercialization schedule of SKY Covione, where item permission was granted. Director Park said, "Even if the vaccine is already approved, the quality will be tested once more in the country before each developer ships it. If SK Bioscience applies for approval for shipment in Korea at the time of shipment of SKY Covione, the MFDS will conduct a quality test and use it according to the health authorities' vaccination plan." Regarding overseas use, Director Park said, "It will be used a lot in other countries only when the WHO's approval is made," adding, "SK Bioscience has submitted an application to the WHO and the EMA is also preparing a pre-rolling review to get permission." Although the first COVID-19 vaccine in Korea has been released, pharmaceutical companies that are currently conducting clinical trials to develop the COVID-19 vaccine are also appearing one after another. Director Park said, "Since most of the basic vaccinations are in place in Korea, pharmaceutical companies are changing their strategies rather than stopping the development of vaccines themselves." He said, "We are preparing for development before additional vaccinations, not basic vaccinations, and the MFDS also held two meetings with developers to prepare guides for the development of additional vaccinations. Guidelines will come out soon," he said. At the briefing, Oh Yoo-kyung, head of the MFDS, said, "SKY Covione is the first domestic COVID-19 vaccine approved by the MFDS." In other words, the clinical trial plan was quickly approved by forming a permission review team to apply a customized pre-consultation system for each non-clinical, clinical, and quality stage, and introduced an immunogenic comparative clinical trial method to expedite a large-scale clinical trial. The MFDS said it has approved SKY Covione for the first time in the world with the same licensing requirements and screening criteria as advanced countries such as the United States and Europe, and has established a test method necessary for vaccine testing at the same time. Director Oh said, "With this permission, Korean companies' ability to develop COVID-19 vaccines has been proven internationally." She emphasized, "We can expect to enter the global vaccine market in the future."
- Policy
- SK Bioscience gets final approval for SKYCovione
- by Lee, Hye-Kyung Jun 30, 2022 05:52am
- Permission for the item COVID-19 Vaccine No. 1 developed and manufactured in Korea is imminent. As a result of discussing SKYCovione's safety and effectiveness, the Central Pharmaceutical Review Committee said that it was recognized for the purpose of preventing COVID-19 based on the immunogenic clinical results compared to Vaxzevria, which was already approved, and that the item could be approved. The MFDS (Director Oh Yoo-kyung) explained the progress of item approval for the COVID-19 vaccine SKYCovione (GBP510) developed and manufactured by SK Bioscience in Korea at 10 a.m. on the 27th. SK Bioscience applied for a preliminary review of quality data on April 15, and an application for item permission was received on April 29. A meeting of the Central Pharmaceutical Affairs Review Committee was held at 4 p.m. on the 26th to advise on the safety and effectiveness of SKYCovione. Based on the submitted data such as clinical trial data for SKYCovione, the committee acknowledged the safety and effectiveness of the drug and discussed whether the item permission was appropriate. In particular, experts' comprehensive opinions were exchanged on overall permits, such as overall views on the effectiveness and safety of vaccines and measures to secure safety after approval. As a result of discussing whether SKYCovione's safety and effectiveness were recognized, safety such as abnormal cases that occurred in clinical trials was judged to be acceptable. However, there was an opinion that the predicted adverse reactions in the local and systemic areas were more likely to be caused by vaccinations such as fatigue, muscle pain, headache, chills, fever, joint pain, nausea, vomiting, and diarrhea in adults younger than the first dose. Unforeseen adverse events related to vaccine administration (4 weeks after administration) occurred in about 13.3% (402/3029 patients) of the vaccine group, the main symptoms were injection site hyperplasia, dizziness, pain, etc., and the control group was about 14.6% (145/996). The serious abnormalities were similar to 0.5% (15 cases, 15 cases) in the vaccine group and 0.5% (5 cases, 9 cases) in the control group, and there was 1 rapid progressive glomerulonephritis, which cannot be excluded from vaccine administration, but it was recovering at the time of submission of clinical trial data. In the immunogenicity results comparing already approved Vaxzevria with a control vaccine, neutralization antibodies formed 2.93 times after 14 days of administration every four weeks over the age of 18, and serum conversion rate was 98.06% in the vaccine group and 87.30% in the control group. It was suggested that the overall safety security plan is appropriate, and it is reasonable to observe and evaluate abnormal cases of special interest similar to existing vaccines as a risk management plan after approval. The Ministry of Food and Drug Safety said, "When compiling the opinions of the committee, it was agreed that SKYCovione could be approved." The MFDS received advice from the COVID-19 treatment, vaccine safety, and effectiveness verification advisory group on June 21 to enhance the expertise and objectivity of the COVID-19 vaccine licensing review process. The effectiveness for permission is recognizable, and safety during clinical trials is acceptable, and abnormal cases of special interest should be observed and information should be collected after permission. The MFDS will review SKYCovione's submission data, comprehensively judge expert opinions, efficacy, effectiveness, dosage, and recommendations obtained from the advice of the COVID-19 vaccine safety and effectiveness committee, and hold a final inspection committee to make a final decision.
- Policy
- ↑The cost of drugs for severe dz by ₩1.79 trillion
- by Lee, Tak-Sun Jun 29, 2022 05:53am
- The proportion of drug costs for four major serious diseases such as cancer and rare diseases is increasing significantly every year. Another reason is the increasing number of expensive new drugs that are listed. As the proportion of drug costs for these four major serious diseases increases, the need for efficient financial management measures is also expected to increase. According to the "2021 reimbursed drug claim status" published by the HIRA on the 27th, the cost of drugs for the four major diseases was 5.6 trillion won last year, accounting for 26.4% of the total drug cost of 21.2097 trillion won. The four major serious diseases refer to cancer, cerebrovascular, heart, and rare and symptomatic incurable diseases. Among them, most of them are cancer and drugs for rare and symptomatic incurable diseases. The cost of drugs for the four major serious diseases increased by 1.79 trillion won in four years from 3.8107 trillion won in 2017. The share of the total drug cost also increased significantly from 23.5% in 2017 to 26.4% in 2021. At this rate, it is expected to exceed 30% soon. Among the four major serious diseases, the proportion of cancer disease drug costs also increased from 12% in 2017 to 14.2% in 2021. In addition, the proportion of drugs for rare and symptomatic incurable diseases also increased from 10.8% to 11.6%. Analysts say that drug costs are also increasing as the health insurance coverage rate for the four major serious diseases is strengthened. However, analysts say that the pace of increase in drug costs will exceed expectations as new drugs targeting certain cancers or rare diseases are increasingly priced. Kymriah, which was recently registered, was listed for 3603 million won, Spinraza 92.35 million won, and Lutathera 22.1 million won. On top of that, the proportion of high-priced drugs for cancer and rare diseases is expected to increase as one-shot treatments worth more than 1 billion won, such as Zolgensma and Luxturna, are waiting for reimbursement one after another. Analysts say that the voluntary reduction in drug prices for MSD's diabetes drug Januvia as MSD Kymriah was listed as the primary drug for non-small cell lung cancer in February is also a case in point of view. The proportion of total drug costs in health insurance medical expenses has been stably managed. Last year, the proportion of drug costs was 24.06%, down from 25.09% in 2017.
- Policy
- Fexclu reimb at ₩939, Kadcyla reimb extended from July
- by Kim, Jung-Ju Jun 29, 2022 05:53am
- Four items including Daewoong Pharmaceutical’s Fexclu Tab (fexuprazan hydrochloride) will be listed at ₩939 per tablet starting next month as latecomers of the homegrown novel drug K-CAB indicated to treat erosive gastroesophageal reflux disease (GERD). Also, reimbursement of Kadcyla (trastuzumab emtansine), Roche Korea’s second-line treatment for breast cancer, will be extended to cover its treatment as ‘adjuvant treatment of patients with early breast cancer after surgery’, and will accordingly receive a new drug price. The Ministry of Health and Welfare held the 14th Health Insurance Policy Deliberation Committee meeting (Chair: 2nd Vice Minister of Health and Welfare, Ki-Il Lee) today (28th) and announced that the listing and reimbursement extension proposals for 2 new drugs and 1 previously listed drug have been passed after deliberation at the HIPDC meeting. The listing of 4 latecomer fexuprazan hydrochloride drugs including Fexclu Tab 40mg, and reimbursement extensions of two items - Kadcyla inj. 100mg and 160mg – passed deliberations and will be applied reimbursement starting July 1st. ◆4 items including Fexclu Tab. 40mg = Four fexuprazan hydrochloride latecomers used to treat erosive gastroesophageal reflux disease (GERD) will be concurrently listed for reimbursement. The 4 items are Daewoong Pharmaceutical’s Fexclu Tab, Hanall Biopharma’s Abcito Tab, Daewoong Bio’s We Cab Tab, and iN Therapeutics’ Veloxcab Tab. The companies had received marketing authorization from the Ministry of Food and Drug Safety for their respective drugs from December 30th last year to January 11th of this year and applied for reimbursement listing from December 27th last year to January 13th of this year. Upon receiving the reimbursement request, HIRA’s Drug Reimbursement Evaluation Committee reviewed the 4 drugs on the 12th of last month and passed the agenda on to the NHIS. During deliberations, DREC decided that the four drugs’ clinical benefit is non-inferior to K-CAB, and is adequate for reimbursement at ₩939, which is 90% of the weighted average of its alternatives. The NHIS then carried out negotiations on the expected claims amount of each item with the companies from May 25th to June 17th. The drug price has been set at ₩939 per each 40mg strength tablet. ◆ Kadcyla Inj 100mg and 160mg = Kadcyla Inj, Roche Korea’s treatment for locally advanced or metastatic breast cancer, had been listed for reimbursement since August 2017. This time, a reimbursement standard for Kadcyla to be administered ‘for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment’ will be added. The company had received additional approval for the above indication on August 8th, 2019 from the MFDS, and requested a reimbursement extension on the same day to HIRA. HIRA had deliberated on the agenda at the DREC meeting held on October 16th of the same year, on August 26th in 2020, and on February 10th. DREC had set the reimbursement standards for Kadcyla in consideration of the reimbursement evaluations made abroad and the additional fiscal sharing plan proposed by the company, after which the DREC members discussed whether the drug should submit pharmacoeconomic evaluation data and be evaluated for its cost-effectiveness. In the case of pharmacoeconomic evaluations, Kadcyla had significantly improved invasive disease-free survival compared to its alternative Herceptin (trastuzumab) and was required to demonstrate its cost-effectiveness. After PE evaluations, DREC decided that the drug’s ICER level was within an acceptable range and is therefore cost-effective. As a result, members at the DREC meeting passed Kadcyla in consideration of how its PE evaluation value was at an acceptable level compared with Herceptin and is listed for reimbursement in all A7 countries. The company thereafter agreed with the NHIS on applying the Utilization cap / Fixed cost per patient type of RSA for Kadcyla's reimbursement, under which the company is required to refund the excess amount used to the NHIS. The agreed price was set at ₩1,956,328 per vial for Kadcyla Inj 100mg, and at ₩2,930,920 for Kadcyla Inj 160mg.
- Policy
- Low strength Esomezole Plus Tab priced same as Eso Duo
- by Lee, Tak-Sun Jun 28, 2022 06:09am
- Hanmi Pharmaceutical has decided to set the ceiling price of its gastroesophageal reflux disease (GERD) treatment combo ‘Esomezole Plus (esomeprazole+ magnesium hydroxide)’ at the same level as Chong Kun Dang’s ‘Eso Duo (esomeprazole+sodium bicarbonate)’ to directly target Eso Duo in the market. Its lower strength formulation, in addition to its higher strength, is setting out to the market at the same price as Chong Kun Dang’s Eso Duo. According to the Ministry of Health and Welfare, Esomezole Plus 20/350mg Tab will be listed for insurance benefit at a ceiling price of ₩720 from the 1st of next month. This is the same price as Eso Duo 20/800mg Tab. Both products contain 20mg of esomeprazole. Hanmi Pharmaceutical had also listed Esomeprazole Plus 40/350mg Tab at the same price as Eso Duo 40/800mg Tab, at ₩920 in April this year. This is interpreted as a head-on challenge made by Hanmi against the current market-leading product, Eso Duo. Eso Duo, a combination of the PPI esomeprazole and an antacid ingredient, is the product that mainstreamed such combinations in the GERD treatment market. Esomeprazole, which is weak in stomach acid is complemented by an antacid to provide a quicker effect. The drug was released in 2018 and exceeded ₩10 billion in sales, the record set for blockbusters, in the year of its release. Last year, its outprescription sales amounted to ₩18.2 billion according to UBIST. In particular, its growth continued despite the release of dozens of Eso Duo generics last year. Although Hanmi has dominance over the GERD monotherapy market, it is a latecomer to the PPI+antacid combination market. Therefore, the company seems to be pushing to overthrow the current leader in the combination drug market, Eso Duo. Although 29 Eso Duo generics are currently listed in the market, no other drug has the same price set for their drugs higher and lower strength formulations as the original. In addition, Esomezole Plus contains a different antacid from Eso Duo. This means that Hanmi could have listed its drug for a higher price, in line with the highest price of esomeprazole, but had lowered its price to compete with the market leader Chong Kun Dang. Therefore, industry eyes are on who will seize victory among the two companies that have the best sales power in Korea. The pride is in line for the two companies, and whether Chong Kun Dang, the pioneer in the combination drug market will continue exerting its dominance in the market, or whether Hanmi, the sole leader of the monotherapy market will become a sensation in the combination drug market remains to be seen.
- Policy
- Phase 3 of Danicopan will be conducted in Korea
- by Lee, Hye-Kyung Jun 28, 2022 06:09am
- Phase 3 clinical trials of Danicopan (ALXN2040), which is called a competitive drug for rare drug Soliris, will be conducted in Korea. The MFDS recently approved a phase 3 clinical trial for patients with seizure night hemoglobinuria (PNH) who had previously been administered Danicopan in a clinical trial commissioned by IQVIA. This clinical trial is an additional therapy for C5i and is a long-term extension (LTE) test to characterize Danicopan's safety and effectiveness. It is conducted at Seoul St. Mary's Hospital, Sung Vincent Hospital, Severance Hospital, Chungnam National University Hospital, Seoul Asan Hospital, and Samsung Medical Center. Danicopan is a PO Factor D inhibitor as a candidate for complement-mediated rare disease treatment such as Paroxysmal nocturnal hemoglobinuria (PNH) and C3 glomerulopy (C3G). In a phase 2 clinical trial conducted in PNH patients, it was found that the average hemoglobin level was increased in combination with the monoclonal antibody drug Soliris binding to C5 complement protein, reducing the need for blood transfusion. Danicopan was designated as an innovative treatment by the US FDA in September 2019 after being designated by the US FDA as a rare drug for the treatment of paroxysmal night hemoglobinuria in 2017. Danicopan is a drug that is being developed for use with C5 protein monoclonal antibodies to treat paroxysmal night hemoglobinuria (PNH), which only exhibited sub-optimal responses when treated using only C5 protein inhibitors. The FDA decided to designate innovative treatments based on positive efficacy and safety data derived from phase 2 clinical PNH combined test of Danicopan.
- Policy
- The first COVID-19 vaccine is expected to be approved
- by Lee, Hye-Kyung Jun 28, 2022 06:09am
- Seo Kyung-won, Director General of the National Institute of Food and Drug Safety EvaluationSK Bioscience's "SKY Covione," Korea's No. 1 COVID-19 vaccine, is expected to receive product permission within this month. Seo Kyung-won, Director General of the National Institute of Food and Drug Safety Evaluation, held a briefing at 10 a.m. on the 27th and said, "We will hold a final inspection committee within this month as possible and conclude the final item approval." The MFDS held a meeting of the safety and effectiveness verification advisory group for SKY Covione, which received item permits on April 29, and held the Central Pharmaceutical Affairs Council on the 26th to decide whether to recognize safety and effectiveness. According to the progress of the COVID-19 vaccine permit review, the final item approval will be granted after the 2nd Central Pharmaceutical Affairs Council and the 3rd final inspection committee following the 1st verification advisory meeting. Director Seo said, "SKY Covione is a meaningful vaccine that has been developed in Korea and completed everything from raw materials to commercialization," adding, "It is difficult to say the final approval date, but we are doing our best to take place within this month." The final inspection committee is a process of final inspection to see if the results of the first and second consultations are properly reflected in the permit, which leads to item approval immediately after this step. Meanwhile, the Central Pharmaceutical Affairs Council discussed whether to recognize the safety and effectiveness of SKY Covione and determined that safety, such as abnormal cases in clinical trials, was acceptable. The approval review is currently being conducted with two basic vaccinations, and additional booster shots will be decided after the clinical trial is completed. She added, "Additional vaccination is a clinical trial stage, and it is necessary to discuss with related ministries such as KDCA in the future whether the fourth additional vaccination is possible in preparation for the re-pandemic of COVID-19 in the fall."
