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- 2026-04-11 18:25:00
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- development of Korea-Japan, the efficacy of COVID-19 drugs
- by Kim, Jin-Gu Sep 30, 2022 05:53am
- Capture the Shionogi homepage. The difference in clinical design from Lagevrio and Paxlovid and the stop of the spread of COVID-19 are also variables. The results of phase 3 clinical trials of Xocova, a candidate for oral COVID-19 treatment under joint development by Ildong Pharmaceutical with Shionogi, Japan, have been announced. In the pharmaceutical industry, it is interpreted that it is one step closer to approval for emergency use in that it has produced meaningful results in shortening the period of symptom improvement, the primary evaluation variable. Some predict that it is difficult to guarantee Emergency Use Authorization because there is a difference in clinical design from Emergency Use Authorized MSD's Lagevrio and Pfizer's Paxlovid, and there was no permission or approval from the U.S. and Europe. ◆Xocova, similar mechanism to Paxlovid, clinical design is different Shionogi announced the results of phase 3 clinical trials of Xocova on its website on the 28th. In a clinical trial of 1,821 mild and moderate patients in Korea, Japan, and Vietnam, patients who administered Xocova showed significantly lower time than those who administered placebo until the five major symptoms of COVID-19 (nose congestion, runny nose, sore throat, cough, and fever) subsided. The time to suppress symptoms was 167.9 hours (about 7 days) in the group administered low dose Ensitrelvir and 192.2 hours (about 8 days) in the group administered placebo. The results of examining how much viral RNA was reduced on the 4th day of administration also showed that the Ensitrelvir administration group decreased significantly compared to placebo. Xocova is designed to block the activity of 3CL protease, a key enzyme needed when the COVID-19 virus (SARS-CoV-2) proliferates in cells. The mechanism is similar to Xocova and Paxlovid, but there is a large difference in clinical design. In the case of Paxlovid, the risk of hospitalization and death decreased by 89% as of the 28th day of administration. As of the 29th day of administration, Lagevrio's risk of hospitalization and death decreased by 30%. There is also a result that additional clinical trials conducted in India and other countries showed 65% effect. Xocova is expected to be less burdened by taking drugs than Paxlovid and Lagevrio. Paxlovid and Lagevrio have many drugs to take at once. Paxlovid is taken twice a day for a total of 5 days as a set of Nirmatrelvir and Litonavir. The total number of pills to be taken for five days is 30. 4 capsules of Lagevrio is taken twice a day for 5 days. The total number of pills taken during the treatment period amounts to 40 capsules. Xocova is taken once a day for a total of 5 days. The number of pills to be taken per episode has not been clearly determined, but it is known that three tablets are taken on the first day and one tablet is taken every day since then. If Xocova is approved EUA in Korea, it will be the third drug for oral COVID-19. The Ministry of Food and Drug Safety conducted EUA on Paxlovid in December last year and Lagevrio in March this year. In the case of Paxlovid, the EUA was decided five days after the request of the Korea Centers for Disease Control and Prevention (December 22, 2021). It is only 48 days, including the period of preliminary review by the Ministry of Food and Drug Safety. Lagevrio took a total of 127 days from the request of the Korea Centers for Disease Control and Prevention (November 17, 2021) to the EUA decision of the Ministry of Food and Drug Safety. Considering the previous cases, Xocova is also expected to take two to four months to make the EUA decision. However, the pharmaceutical industry's prospects are mixed as to whether the Ministry of Food and Drug Safety will finally decide Xocova's EUA. A pharmaceutical industry official said, "When Japan withheld its judgment on EUA in July, we agreed to wait for phase 3 results to see more accurate data and make a final decision," adding, "We confirmed the effect of improving symptoms through large-scale clinical trials, so the possibility of EUA in Japan has increased. If the EUA is decided in Japan, it will also help the EUA in Korea, he predicted. Some predict that the EUA will be difficult considering the domestic COVID-19 epidemic. Paxlovid & Lagevrio Shionogi applied for Xocova's conditional permission to the Japanese Ministry of Health, Labor and Welfare in February this year. Since then, the EUA application bill in Japan has been passed, and in June and July, the Ministry of Health, Labor and Welfare and Food Sanitation Council discussed whether to do so. The Pharmaceutical Affairs Council mainly said, "It is effective in reducing the amount of the virus, but there is not enough data to improve clinical symptoms." In Korea, Ildong Pharmaceutical plans to launch EUA regardless of Shionogi. In August, domestic clinical trials were completed. Ildong Pharmaceutical plans to apply for EUA in Korea by submitting the results of phase 3 clinical trials in Japan along with domestic clinical results.
- Policy
- Research service for re-evaluation of listed drug benefits
- by Lee, Tak-Sun Sep 30, 2022 05:53am
- The HIRA will conduct a study on the re-evaluation of drug benefit adequacy with the aim of ending in February next year. Through this, it will be used as a policy to promote re-evaluation projects. The HIRA announced on the 27th that it would bid for a research service to rationalize the evaluation of drug benefit adequacy. Ticketing is scheduled to take place on October 5. The research period is four months from the date of signing the contract, and the goal is to end in February next year. The budget was allocated 60 million won. The HIRA explained that through this study, it will come up with a reasonable target selection and evaluation standard improvement plan to stably establish a benefit adequacy re-evaluation system, operate an effective system, enhance predictability of stakeholders, and prevent unnecessary issues. Re-evaluation of drug benefit adequacy is being conducted by the first comprehensive health insurance plan (2019-2023). Therefore, the relevant grounds will be lost next year. This year, The HIRA has prepared criteria for selecting the grand prize, but there is no research to support this. In the first half of last year, the HIRA set the criteria for the long-standing registration year when selecting the subject for re-evaluation, and decided to evaluate the clinical usefulness first, considering cost-effectiveness and social demands if necessary. This is why this study is necessary because the re-evaluation does not achieve the purpose of reducing insurance finances immediately. The HIRA is suspended from administrative litigation and execution by pharmaceutical companies in all three components and Choline alfoscerate in 2020. The committee pointed out that the achievement of the purpose of the system is insufficient and that the reduction of insurance finances is being delayed. Accordingly, this study plans to conduct policy proposals for selecting targets for re-evaluation and improving evaluation criteria and methods through analysis of domestic and foreign reimbursed drugs, and adequacy re-evaluation system. The main contents of the study are policy suggestions for analyzing the current status and revaluation (post-management) system in Korea, analyzing the overseas revaluation (post-management) system and status, and re-evaluating the rational drug benefit appropriateness (spending efficiency). The HIRA expected that this service study will be used as a policy for selecting targets related to the promotion of drug benefit adequacy re-evaluation projects and managing reimbursed drugs.
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- 1st KRAS drug Lumakras can be prescribed at general hospital
- by Eo, Yun-Ho Sep 29, 2022 05:50am
- Lumakras, the first targeted anticancer therapy to target the KRAS mutation, can now be prescribed at general hospitals in Korea. According to industry sources, Lumakras (sotorasib), Amgen Korea’s treatment for locally advanced or metastatic non-small cell lung cancer with KRAS G12C mutations, passed the drug committees of the Big 5 tertiary hospitals in Korea including the Samsung Medical Center, Seoul National University Hospital, Seoul Asan Medical Center, and Sinchon Severance Hospital, as well as other medical institutions nationwide, such as the Gangnam Severance Hospital, Korea University Anam Hospital, National Cancer Center, Seoul National University Bundang Hospital, Chungnam National University Hospital, Kyungpook National University Chilgok Hospital, and Chonnam National University Hwasun Hospital. Considering that the drug was approved in Korea in February and not listed for reimbursement yet, the drug is quickly settling in medical institutions in Korea. Amgen is currently preparing for its reimbursement in Korea. Lumakras is approved for use as second-line or subsequent treatment in adult patients with KRAS G12C-mutated, locally advanced, or metastatic non-small cell lung cancer. Lumakras is the first targeted therapy to be approved by the Ministry of Food and Drug Safety for KRAS G12C NSCLC patients. KRAS is one of the major oncogenes is found in various cancers including NSCLC and is present in 25% of all NSCLCs. It is the second-most common mutation that occurs in Asian patients after EGFR mutations. NSCLC patients with the KRAS G12C mutation have shown a lower relative survival rate than other lung cancer patients in surgery or chemotherapy as many are resistant to existing standard therapies. Lumakras is the first-ever oral treatment that selectively inhibits the KRAS G12C mutant protein that is involved with the development of lung cancer. It inactivates the KRAS G12C mutant protein that promotes tumor growth to effectively block the signaling oncogenic activity without affecting the wild-type KRAS. Professor Myung Ju Ahn from the Samsung Medical Center said, “KRAS G12C-mutated NSCLC is an area where a dire need remained for a new treatment option. The domestic approval of Lumakras, the first targeted therapy for KRAS G12C mutated NSCLC, is news that both the patients and the field have been long awaiting for. Based on the excellent treatment effect and safety profile confirmed in clinical trials, Lumakras is expected greatly contribute to improving the prognosis of patients if introduced to the field.” Meanwhile, the efficacy of Lumakras was demonstrated through the Phase II CodeBreaK100 trial that included 124 patients with KRAS G12C-mutated locally advanced or metastatic NSCLC. Patients enrolled in the trial had all progressed after chemotherapy or immunotherapy. Results showed that the overall response rate (ORR) that includes both partial and complete responses was 36%. Also, 82.3% of the patients treated with Lumakras showed tumor shrinkage, with a media maximum tumor shrinkage of 60% in all responsive patients, showing a consistently high treatment effect.
- Policy
- Withdrawal of Hanmi's Olita permit, cancellation of benefit
- by Lee, Tak-Sun Sep 29, 2022 05:50am
- The benefit of Olita, a new domestic drug, will be canceled following the withdrawal. It has been six years since it was approved as the new domestic drug No. 27 in May 2016. Since Hanmi Pharmaceutical already announced the suspension of development in April 2018, the withdrawal of the license and cancellation of the benefit were scheduled, but it withdrew from the market due to global competitive drugs. According to the industry on the 28th, Hanmi Pharmaceutical's non-small cell lung cancer treatment drugs Olita 200mg and Olita 400mg will be removed as of the 1st of next month. It is a procedure following the withdrawal of permission. Olita has maintained permits for existing patients permission was withdrawn on 12 August. Hanmi Pharmaceutical, which received phase 3 from the Ministry of Food and Drug Safety, decided to suspend Olita's development in April 2018. This is because it was expected that it would be difficult to recruit phase 3 clinical patients as a competitive drug called Tagrisso quickly entered the market.The return of Olmutinib rights by Beringer Ingelheim and its Chinese partner Zai Lab affected the suspension of development. Tagrisso of AstraZeneca, a competitive drug, started selling around the world and received benefits in Korea, making it difficult to recruit patients necessary for phase 3 progression. Although Olita's domestic application was November 15, 2017, a month earlier than Tagrisso's (December 15, 2017), Tagrisso's benefit is a problem for Olita's domestic development because it had to proceed with a phase 3 clinical trial, which is a condition of permission. However, while the development was suspended, the permission was maintained for patients taking Olita at the time, but the permission and cancellation were a matter of timing because they did not meet the conditions of the permission, phase 3.
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- Ildong applies to change trial protocol after completion
- by Kim, Jin-Gu Sep 29, 2022 05:50am
- Ildong Pharmaceutical and Shionogi Pharmaceutical submitted an application to modify their clinical trial protocol after completing the Phase 3 trial for their COVID-19 treatment. The industry saw this as Shionogi Pharmaceutical’s intent to reinterpret the clinical trial results around the Omicron variant. On the 27th, Ildong Pharmaceutical publicly announced that it applied to modify the Phase 2/3 clinical trial protocol for its oral COVID-19 treatment candidate 'S-217622 (brand name: Xocova).’ According to the public announcement, the biggest change was made in Cohort A’s Phase III trial size that is being conducted on moderate-to-severe COVID-19 patients. Cohort A’s Phase 2b trial size had been 428, and Phase 3 1821. Through the modification, Ildong and Shionogi decided to increase the Phase 2b trial size for Cohort A to 435, and reduce the Phase 3 trial size to 780. The size of Phase 2b and Phase 3 trials for Cohort B, which are being conducted concurrently and enrolled asymptomatic and mild COVID-19 patients, will also be reduced from 605 to 495. However, the number of participants enrolled in Cohort A and Cohort B are not that different in Korea, 204 and 200, respectively. The reason why the modification application had been receiving interest was that the two companies had already completed the global Phase III trial for Xocova. The two companies completed observation of the final trial participant on August 14th and submitted the clinical trial completion report to regulatory authorities. This is why the industry analyzes the companies’ applied for the change to reinterpret the clinical trial results, focusing on the Omicron variant. When the clinical trial was first designed, the company enrolled COVID-19 patients infected with the original (Wuhan) strain and Omicron variant in Korea. However, as time went by, the Omicron variant became the dominant strain, which naturally shifted the treatment target to the Omicron variant as well. At the same time, some industry experts analyzed that the reinterpretation of clinical trial results was Shionogi’s strategy to raise the possibility of receiving Special Approval for Emergency in Japan. Shionogi submitted an application for the conditional approval of Xocova to Japan’s Ministry of Health, Labor and Welfare in February this year. After the bill for the Special Approval for Emergency was passed in Japan, emergency use of Xocova had been discussed by MHLW’s expert committee. However, the conclusion was for the agenda to be redeliberated by MHLW’s Pharmaceutical Affairs and Food Sanitation Council. Although a second discussion was made by the council in July, the council decided to further discuss the issue in the future. An official from Ildong Pharmaceutical said, “The application for modification that was submitted this time was led by Shionogi. The company is known to have filed the application to re-review the result around subjects affected by the Omicron variant in line with the current situation where the Omicron variant is the dominant strain.”
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- FDA approved Celltrion's anticancer drug Avastin biosimilar
- by Chon, Seung-Hyun Sep 29, 2022 05:50am
- The 3.6 trillion won U.S. market has begun in earnest. Celltrion announced on the 27th that it has obtained a license from the Food and Drug Administration (FDA) to sell the Avastin biosimilar Vegzelma. Vegzelma has been approved for Avastin's indications, including metastatic direct bowel cancer, non-small cell lung cancer, metastatic renal cell cancer, cervical cancer, epithelial ovarian cancer, ovarian cancer, ovary cancer (uterine cancer), primary peritoneal cancer, and circulating glioblastoma. Since August, Celltrion has sequentially obtained sales licenses for Vegzelma from regulators in major global countries such as Europe, the United Kingdom, and Japan. According to IQVIA, a global pharmaceutical market research firm, Avastin's global market reached $6.43 billion last year. The U.S. market is about $2.62 billion, the largest in the world, on a single scale. Celltrion plans to quickly settle Vegzelma in the global market with cost competitiveness from its own drug development and production know-how. Celltrion completed a global patent agreement with Genentech, the developer of original drug Avastin, in May and laid the foundation for stable launch of Vegzelma in the global market. Celltrion Healthcare, which is in charge of selling and marketing Celltrion products, plans to launch Vegzelma in the global market sequentially, including major European countries in the second half of this year. An official from Celltrion explained, "We have obtained all the permits from major countries such as Europe, the United States, and Japan, and are ready to target Vegzelma's global market." He said, "We will do our best to settle in the global market as soon as possible with Vegzelma's cost competitiveness, and to proceed with clinical trials and permits of other biosimilar products currently being developed."
- Policy
- Boryung Zepzelca, conditional approval with phase 2 data
- by Lee, Hye-Kyung Sep 29, 2022 05:49am
- It has been confirmed that Boryung's new small cell lung cancer drug Zepzelca has received conditional approval only with phase 2 clinical data. Based on the Ministry of Food and Drug Safety's notice, anti-cancer drugs have been subject to conditional approval for phase 3 since January this year, and the revision of the Pharmaceutical Affairs Act has clarified the criteria for conditional approval only with phase 2 data. The HIRA benefit evaluation will be available if the company applies for conditional approval. If the adequacy is evaluated in the HIRA, it can be converted into a reimbursed drug through drug price negotiations with the NHIS. Until the benefit is applied, patients will be able to receive Zepzelca on a nonreimbursed basis only for permits. On July 6, the Central Pharmaceutical Affairs Review Committee, which was unveiled by the Ministry of Food and Drug Safety on the 27th, discussed the efficacy of Zepzelca's conditional approval. According to the minutes, the Ministry of Food and Drug Safety judged that the number of patients was reasonable because the phase 3 clinical trial proposed by Boryung was a multinational clinical trial. In addition, Zepzelca submitted a risk management plan as a rare drug, and added that it focused on hematological toxicity and hepatotoxicity in safety items. At the meeting, Boryung said, "We plan to proceed only with global clinical trials at the moment, and if we believe that domestic clinical trials are necessary, we will decide after discussing with developers." "In the United States, discussions have been held with the FDA several times since the phase 2 clinical trial, and conditional items have been approved and are currently on the market," he explained. Phase 3 clinical trials are currently underway, and plans to submit phase 3 clinical data as soon as clinical trials are completed in the future. Boryung announced its plan to launch Zepzelca in the first half of next year, which is an indication of "metastatic small cell lung cancer that failed primary platinum-based chemotherapy." Zepzelca is a new anti-cancer drug developed by Spanish pharmaceutical company PharmaMar S.A., and Boryung has exclusive rights to develop and sell in Korea since 2017. After being designated as a rare drug by the U.S. Food and Drug Administration (FDA) in 2018, it was released in July of the same year with conditional rapid approval and priority screening approval in June 2020. In the United States, only small cell lung cancer is allowed. Boryung said, "Although it was a phase 2 result, it showed effectiveness compared to existing treatments, and showed a low tendency in hematological adverse reactions in terms of safety," and expected, "If it is marketed, patients' choice opportunities will be expanded."
- Company
- Daewoong Pharmaceutical SGLT-2 Diabetes New Envlo
- by Kim, Jin-Gu Sep 28, 2022 06:06am
- Daewoong Pharmaceutical has registered a trademark of Enavogliflozin, which is being developed as a new drug for treating diabetes in the line of SGLT-2 inhibitors. Daewoong Pharmaceutical temporarily confirmed the name of the single, second, and third complex series centered on Enavogliflozin as Envlo, and began the last-minute work with the aim of approving items in the first half of next year. According to the pharmaceutical industry on the 28th, the Korean Intellectual Property Office recently decided to register the trademark Envlo applied for by Daewoong Pharmaceutical. Daewoong Pharmaceutical applied for this trademark late last year. At that time, Daewoong Pharmaceutical also applied for the brand ENAZIN, ENAVOX, and BENAVO at the same time. This year, it applied for additional trademarks such as Enaflo, Eaglex, Glucut, Imabec, Imatin, and Imatide. All of these trademarks are confirmed to have applied for "drugs for treating diabetes" as designated products No. 1. Among them, Daewoong Pharmaceutical finally decided to use the name Envlo after an internal review. The rest of the applied trademarks are expected to be used as the names of drugs with the same ingredients of related companies such as Daewoong Bio and Hanol Biopharma. Daewoong Pharmaceutical recently applied for the trademarks ENVLOMET and ENVLOJEM. It is interpreted that Daewoong Pharmaceutical is likely to be a strong brand name in that it is conducting clinical trials of Metformin combi and Metformin and Gemigliptin 3 combi drugs at the same time with Enavogliflozin. Daewoong Pharmaceutical plans to continue its plan to license items and release products after trademark registration. Daewoong Pharmaceutical applied for an item permit for Enavogliflozin in April. It then plans to release a single and complex system in the first half of next year after obtaining an item license in the second half of this year. Earlier, in the first quarter of this year, the results of the phase 3 clinical top-line for Enavogliflozin and combination therapy were announced, and statistical significance of the difference in HbA1c change in monotherapy and safety in combination therapy were confirmed.
- Company
- 4th JAKi Cibinqo makes a step towards reimbursement
- by Eo, Yun-Ho Sep 28, 2022 06:06am
- The 4th JAK inhibitor, Cibinqo, is nearing insurance reimbursement in Korea. According to industry sources, Pfizer Korea’s new Janus kinases (JAK) inhibitor ‘Cibinqo (abrocitinib)’ passed the review of the National Health Insurance Review and Assessment Service’s Drug Reimbursement Standard Subcommittee. The company applied for Cibinqo’s reimbursement in April. Its competitors -’ Lilly Korea’s ‘Olumiant (baricitinib)' and Abbvie’s ‘Rinvoq (upadacitinib)’ – have already been receiving reimbursement for the atopic dermatitis indication since May. Considering how the company made the strategic move to accept the weighted average price of its alternative drugs, its progress is not on the faster side. However, as the remaining steps to reimbursement can be accelerated with the will of the pharmaceutical company, Cibinqo’s may be launched with reimbursement within this year. Cibinqo is a JAK1 inhibitor that modulates multiple cytokines involved in the pathophysiology of atopic dermatitis, including interleukin IL-4, IL-13, IL-31, IL-22, and thymic stromal lymphopoietin (TSLP), etc. It is indicated for the treatment of adults and adolescents over the age of 12 with moderate-to-severe atopic dermatitis. Cibinqo demonstrated its efficacy through the Phase III trials JADE MONO-1, MONO-2, COMPARE, etc. The drug reduced the Eczema Area and Severity Index (EASI) by over 70% at Week 12 and demonstrated improvement in itch relief within 2 weeks after initiating treatment. Its pivotal study, JADE Mono-1, was designed to evaluate the efficacy and safety of two doses (100 mg and 200 mg once daily) of Cibinqo monotherapy vs placebo in randomly assigned patients 12 years of age and older with moderate-to-severe AD for 12 weeks. Results showed that 63% of the Cibinqo 200 mg administered group had achieved EASI-75 (improvement of at least 75% in lesion extent and severity) at week 12, which was a significant improvement compared to the 12% in the placebo group. Also, the rate of patients that achieved EASI-90 at week 12 had been 39% in the Cibinqo group, 5% higher than the placebo group
- Company
- MFDS allows academic marketing of EUA COVID-19 treatments
- by Sep 28, 2022 06:05am
- The Ministry of Food and Drug Safety gave an interpretation that allows academic marketing activities for oral COVID-19 treatments. As drugs approved under the Emergency Use Authorization are as validly approved as officially authorized drugs, such drugs that were left unattended by the Pharmaceutical Affairs Act can also be advertised within its approved indication. With this favorable interpretation, the healthcare professionals’ access to information that arose as a barrier in prescribing COVID-19 treatments will also gain momentum and be improved. During a phone interview with Dailypharm on the 26th, an official from the Ministry of Food and Drug Safety said, “The Korea Disease Control and Prevention Agency is in charge of the overall management of EUA drugs, from its use volume to distribution. Therefore, the KDCA needs to determine the need for the drugs’ advertisement, etc. Although academic marketing is not necessary for EUA drugs as they are not directly sold by individual pharmaceutical companies, the companies may jointly provide information with the KDCA for reasons such as raising the prescription rate, etc. The official added, “Applying the Pharmaceutical Affairs Act mutatis mutandis for such academic marketing activities mean that the companies that received EUAs for their drugs can advertise their products within their approved indications as the EUA is also a form of ‘authorization' subject to the mutatis mutandis application of the Pharmaceutical Affairs Act. It does not mean we are forbidding academic marketing activities of pharmaceutical companies.” Until now, advertising of EUA drugs had been left in the blind spot with no clear regulations. The EUA system was introduced under the Special Act on the Promotion of Development and Urgent Supply of Medical Products in Response to Public Health Crisis to promptly respond to the rise of new infectious diseases. The law does not have specific regulations set for the advertisement of EUA drugs. As no issues relevant to such had risen until recently, the MFDS had taken a principled position, saying that “no advertisement-related regulations are available under the Special Act, therefore the issues are applied mutatis mutandis to the Pharmaceutical Affairs Act.” Pharmaceutical companies had taken this as a “No advertising” stance, as EUA drugs are not subjects for advertisement under Article 68-5 of the Pharmaceutical Affairs Act. The article specifies that an imported pharmaceutical product’s name, manufacturing method, and efficacy cannot be advertised unless the drug product has been approved or reported according to Article 42-1 of the Pharmaceutical Affairs Act. If taken word by word, as drugs granted Emergency Use Authorization was not approved under Article 42-1 of the Pharmaceutical Affairs Act, such drugs are not allowed to conduct advertisements. Also, at the time of introductions, when pharmaceutical companies had asked the MFDS several times on what scope of information provision activities are allowed for their EUA drugs, the MFDS only responded that “It is difficult for the ministry to provide a definite answer due to lack of information in determining the necessity and validity of providing information." The pharmaceutical companies then received the response as a “Don’t.” This was why officials from pharmaceutical companies had been passive in conducting activities for their drugs, only responding when receiving inquiries from healthcare professionals. Unlike formally approved drugs, companies were unable to conduct educational or promotional activities such as directly explaining their drugs or delivering drug information to healthcare professionals. However, the Advisory Committee on Infectious Diseases deems the academic marketing activities of pharmaceutical companies necessary to raise the prescription rate. During a phone interview with Dailypharm, Gi-Seok Jeong, Director-General of Special Response of the Central Disaster and Safety Countermeasure Headquarters, said, “Despite the state’s efforts in encouraging the prescription of oral COVID-19, there are still many cases in which prescriptions are not available to patients who need them in the medical field. Adding pharmaceutical companies' information provision activities to the effort will help increase the prescription rate.” In other words, although the KDCA is in charge of training healthcare professionals and providing medication guidance to patients, etc., for the EUA drugs, it has been experiencing limitations with the expanded number of institutions that can prescribe oral COVID-19 treatments It was found that many medical staff and pharmacists have not yet received the prescription and medication guide, which is creating confusion in the medical field. This is analyzed to have also impacted the slow rise in the prescription rate of COVID-19 treatments. According to the 'Measures to Raise Prescriptions of Oral COVID-19 Treatments’ that had been reported by CDSCH last month, healthcare professionals were reluctant to prescribe oral COVID-19 treatments due to a large number of contraindicated drugs and lack of clinical information. Accordingly, the authorities are contemplating ways to increase accessibility to information by preparing educational materials and prescription guidelines. The MFDS said that there was a miscommunication in the course of interpreting the Pharmaceutical Affairs Act. Still, the MFDS is presumed to have had a negative stance on advertising activities of COVID-19 treatments in the earlier stages of introduction. It is believed as the KDCA is in charge of providing information, there is no reason for the company to conduct additional academic marketing. However, with the emphasis put on expanding access to information among healthcare professionals, it seems that the MFDS has broadened its scope of interpretation to “Companies may advertise if KDCA deems it necessary.” Furthermore, the MFDS has formalized its position that even drugs approved under EUA may conduct academic marketing activities just like drugs that have received official approval. An MFDS official said, "As KDCA is in charge of supplying and managing the EUA drugs, companies may of course cooperate with the agency when it needs support. When the KDCA requested on a similar note in the middle of this year, we answered that such activities can surely be conducted if the government deems it necessary.”
