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- 2026-05-14 01:42:43
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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.”
- Company
- 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.”
- Policy
- Janssen's Talquetamab, approved for Phase 3 in Korea
- by Lee, Hye-Kyung Sep 28, 2022 06:05am
- While Janssen's Talquetamab is undergoing phase 3 clinical trials around the world, phase 3 approval has been granted to 44 patients in Korea. On the 26th, the Ministry of Food and Drug Safety approved the Talquetamab subcutaneous injection and Daratumumab subcutaneous injection (Tal-DP) or Daratumumab subcutaneous injection and Daratumumab subcutaneous injection (Dalatum-3) in clinical trial subjects with at least 1st prior therapy. Currently, multinational clinical trials are underway for patients with recurrent or refractory multiple myeloma, and the total number of clinical trials is 810. In Korea, clinical trials will be conducted at Severance Hospital, Samsung Medical Center, Hwasun Chonnam National University Hospital, Seoul St. Mary's Hospital, Seoul Asan Medical Center, Seoul National Cancer Center, Gil Hospital, Chonbuk National University Hospital, and Dong-A University Hospital. A double antibody is an antibody that simultaneously recognizes two different antigens. Treatments are characterized by targeting both factors that cause disease. For example, it can act on immune cells and cancer cells at the same time to catch two rabbits, strengthening immunity and attacking cancer cells. Representative double-antibody anticancer drugs include Amgen's acute leukemia treatment BLINCYTO (Blinatumomab) and Roche's hemophilia type A treatment HEMLIBRA (Emishzumab). Talquetamab targets both GPRC5D and CD3 of T cells, a new multiple myeloma target, with off the shelf T cell-redirecting double antibody. According to data released by ASCO last year by Janssen, subcutaneous administration of phase 2 recommended doses in 30 patients with recurrent or refractory multiple myeloma with a median value of 6 months or more was 70%, and 60% of patients achieved VGPR (very good partial response). Subjects of clinical trials previously received the sixth treatment at a median value, and 87% did not respond to the last treatment. Reactions were observed in 70% of patients, including 65% of patients who were non-responsive to three drugs and 83% of patients who were non-responsive to five drugs, and during the 6.3 months of the follow-up period, patients have not yet reached the median of the response period.
- Company
- Reduce steroid in long-term use of Dupixent in asthmatic pts
- by Sep 28, 2022 06:05am
- Sanofi's Dupixent was found to improve major symptoms in a three-year long-term follow-up of severe asthma patients while reducing the use of oral corticosteroids. The results of these studies were released at the 2022 ERS Annual Academic Conference held from the 4th to the 6th. Through this conference, Dupixent released a number of data and RWE data confirming the improvement effect of asthma symptoms related to type 2 inflammatory biomarkers to solidify the treatment effect and safety profile in type 2 inflammatory severe asthma. It proved that it is a treatment that reduces the frequency of deterioration of severe asthma and lowers the severity, thereby helping to reach the treatment goal of severe asthma. Post-analysis study data from VENTURE/TRAVERSE clinical trials once again suggested that Dupixent could be a treatment solution for severe asthma patients, including Steroid-dependent patients. According to published data, Dupixent reduced steroid use for three years while improving major symptoms of asthma, including severe annual exacerbation and lung function deterioration. The results of this post-analysis study were conducted on Steroid-dependent asthma patients who participated in the VENTURE study, the existing phase 3 clinical trial of Dupixent. Patients who were administered Dupixent 300 mg or placebo every two weeks in the existing VENTURE clinical trial received additional Dupixent for up to 96 weeks through TRAVERSE clinical trials. These patients were analyzed by dividing them into patients who used Steroids less than or equal to 10 mg per day. If the daily usage exceeds 10 mg, caution is needed as it can be exposed to steroid side effects such as diabetes and osteoporosis in the long run. According to the main results, Dupixent decreased the annual severe asthma exacerbation rate of patients regardless of Steroid use at 96 weeks from the end of the previous study, VEUNTURE. Among patients with daily Steroid use exceeding 10 mg, the placebo-administered group showed an improvement of more than 81% in the annual severe asthma exacerbation rate at 96 weeks of Dupixent administration. It was also found to have improved by more than 43% in the existing Dupixent administration group, confirming the effect of Dupixent in Steroid-dependent asthma patients. In the group of patients with daily steroid use of 10mg or less, it was found to have improved by more than 80% and 36%, respectively, compared to the baseline of the VENTURE study. Steroid use also decreased as asthma symptoms improved with Dupixent. Dupixent reduced Steroid use by more than 70% at 96 weeks of administration, regardless of both Dupixent/ placebo administration and Steroid use compared to the baseline of the VENTURE study. Patients with daily steroid use exceeding 10 mg also decreased by 83%, confirming the long-term treatment effect of Dupixent in Steroid-dependent patients. The data released on that day also included RWE data from the United States analyzed for severe asthma patients who received Dupixent. According to the data, Dupixent reduced the rate of emergency room visits related to asthma by up to 73.4%, and the rate of hospitalization by up to 66.7%. In addition, it has been confirmed that medical expenses related to asthma have been reduced by reducing the frequency of visits to internal medicine.
- Policy
- Generic for Acelex will be released
- by Lee, Tak-Sun Sep 27, 2022 05:51am
- A new domestic anti-inflammatory drug developed by Crystal Life Science Generic drugs of the domestic anti-inflammatory drug Acelex developed by Crystal Life Science will be on the market from next month. It has been seven years since Acelex was licensed in Korea, and attention is being paid to whether generic, like the original, will be able to expand its market. This is because Celecoxib has high market dominance among coxib families. According to industries on the 26th, eight Acelex generics will be listed on the 1st of next month. Generic companies are Daewoong Pharmaceutical, Hutecs, Ilhwa, CrystalLife Science, Kuhil, Edenpharma, CMG Pharma, and Hana. Except for Daewoong Pharmaceutical, seven items will receive an additional amount of 522 won for one year, including first generics, and will be adjusted to 470 won on October 1 next year. Daewoong will be listed at 597 won, but will also be adjusted to 470 won on October 1 next year. Generic is in competition with original, but Acelex generic is in partnership with original. This is because Crystal Life Science, an affiliate of Crystal Genomics, produces products like the original company. Therefore, the original company's production performance will expand only when generic sales increase. Original and generic market expansion, by having common goals. Cerebrex 400 billion won in annual performance record. 2016, patent expiration as a generic is reimbursed. Acelex is properly lost the use of force and with earnings of less than 10 billion won per year. The sluggishness of Arcoxia and Acelex is due to the fact that the indication is limited to osteoarthritis and that the marketing ability was not great to destroy Cebrex's position. Since large companies such as Daewoong Pharmaceutical are included in Acelex generics this time, generics are expected to expand the overall market size, allowing both original and generics to create synergy.
- Company
- MOHW's view of ‘few’ and ‘pediatric’ for PE exemptions
- by Eo, Yun-Ho Sep 27, 2022 05:51am
- Chang-Hyun Oh, Director of Pharmaceutical Benefits at the Ministry of Health and Welfare Although yet to be finalized, the PE exemption criteria will not be amended' in the direction desired by pharmaceutical companies. In particular, companies are likely to have little room in utilizing the special exemption of the pharmacoeconomic evaluation system due to the restrictions set, such as treatments that are used by ‘few’ patients and those with ‘pediatric’ indications. The period for industry opinion collection still remains, with the deadline being the 30th. But as the government is determined to implement the amendments to the system, to what extent the opinions will be reflected remains to be seen. Chang-Hyun Oh, Director of Pharmaceutical Benefits at the Ministry of Health and Welfare, said so regarding the “Measures to Improve Patient Access and Manage Reimbursement of High-Priced Severe Disease Treatments" at a recent meeting with the multinational pharmaceutical company press gallery. The ‘Few’ patients standard to be maintained at a 200-patient level The government's improvement plan raised industry concerns because it changes the major premise set for PE exemptions. The new change adds ‘few numbers of subject patients’ as a prerequisite for PE exemptions. Originally, the condition was a ‘OR’ clause included with other optional clauses such as ‘if a single-arm study was conducted,’ under Subparagraph 2(c) of Regulation for Drugs Subject to PE Exemptions. The ‘few’ was defined to be in the 200 range. Although the exact number has not been specified in the condition, the PE exemption evaluations has been made at that level. Therefore, there were many opinions in the industry that the number defined as a ‘few’ should be adjusted upward if the condition was to become a prerequisite. However, Director Oh said, “We don’t plan to change the standards we set to define the ‘few’ just because of the amendment. However, no specific number is universally applied to all drugs, therefore, the number may be flexibly adjusted to a small extent for each drug in the future." In other words, if the amendment is applied as is, all drugs that seek PE exemptions will first have to satisfy the 'few numbers of patient' (around 200) requirement, then receive recognition from the committee for their difficulty to generate PE data. What about drugs that have broader indications that are applied to pediatric to adult patients? The main point of the system improvement being made was to improve coverage for pediatric patients. The government had added the clause 'drugs used to treat pediatric patients that are therapeutically equivalent or has no available treatment option, and demonstrates improvement in quality of life or is otherwise approved by the committee.' In essence, the added clause excluded the 'life-threatening disease' condition for PE exemptions just for pediatric patients. In other words, if drugs used for pediatric patients satisfy the remaining conditions, the PE exemption may be applied even if the condition is not life-threatening. On the surface, it seems like an encouraging improvement. However, there were wild speculations in the industry on what the scope of 'drugs used in pediatric patients' will be. The government had not specified whether the 'drugs used to treat pediatric patients' clause applies only to diseases that occur only in children, drugs that only have indications for children, or drugs that can be prescribed broadly to children and adults. However, it is likely that this clause will also not be widely applied. Director Oh said, “It is difficult to provide a clear answer on that part. However, the system was not intended to limit the indication of drugs that can be used for even the adults to only children so that they can take the PE exemption track."
