[헬스코리아뉴스 / 이순호] Celltrion’s Corona 19 treatment’Rekironaju’ was caught in suspicion of transparency about the results of clinical trials two days after requesting approval from the Ministry of Food and Drug Safety. It is said that the development process is unconventional, but there are observations that the controversy may increase as Celltrion, the party, as well as the Food and Drug Administration, which is the permitting authority, are not specifically mentioned.
The Pharmaceutical Association for the Healthy Society issued a statement on the 31st of Gurabb and raised suspicion on the clinical development process, saying, “The government should transparently disclose and evaluate the clinical trial results of Celltrion treatment.”
Previously, the Ministry of Food and Drug Safety (KFDA) received an application for product approval for the Corona 19 treatment’Regdanvimab, code name: CT-P59′ developed by Celltrion on the 29th. He said he would decide.
In this regard, the health drug said, “If Celltrion’s Rekirona state is approved by the Ministry of Food and Drug Safety, it will become the world’s first new drug for COVID-19 antibody treatment, unlike the treatments in Eli Lilly and Regeneron approved for emergency use in the United States.” In the process, a cool view of the safety and effectiveness of drugs needs to be resolved, along with some concerns about whether they are missing or not.”
“In the case of Rekirona, unlike the turbulent reactions so far, no data on known clinical effects have been disclosed,” said Konkuk. “In general, when developing new drugs, the results of clinical trials were published in academic journals. It is also against the common practice of being verified. In particular, the publicly funded clinical trial results are published in journals that are freely publicly available, and all clinical trial results are publicly disclosed.”
“The effectiveness and stability of new drugs cannot be evaluated by unilateral promotion of pharmaceutical companies, and it is international common sense to maximize the transparency of the new drug R&D process and result reporting,” said Konkuk. “Nevertheless, Celltrion said, “The safety of CT-P59 • It is said that detailed clinical data related to efficacy will be kept private until further instructions are provided at the request of the Ministry of Food and Drug Safety.”
“It is hard to believe the news that the Ministry of Food and Drug Safety has blocked the disclosure of data, even if the permit authorities enforced it to be publicly verified by various experts,” said Gunnyak, stressing the need to resolve the suspicion.
It was also pointed out that dry medicine is a public medicine developed with enormous support from the government. In addition to supporting R&D expenses and clinical trial costs, clinical trials are conducted in order to shorten the recruitment period for clinical trial patients from 2 to 3 years, as well as approval of clinical trial plans that usually take 6 months to 1 year, enormous administrative support required for approval. It is a result of public R&D that has invested considerable public funds such as consortium establishment (government fund) and linkage support.
In the case of dry medicine, citing the general conditions and special conditions of the KCDC service contract, “The authority of the KCDC for the relevant R&D results is also clearly stated. The pre-approval procedure for the use of research results is also being prepared and operating,” he said. “But, so far, the public has nothing to know about this development process.”
“What the people want is a safe and effective domestic COVID-19 treatment,” said Konkuk. “It should not be forgotten that the demand for transparency in clinical trial results is the basic right of the people to receive safe and effective treatment. The government urged to immediately and transparently disclose information and guarantee the legitimate rights of the people.”
He also said, “You should not be asked to believe in the effectiveness and safety of the treatment, as a reporter briefing by the head of the National Institute of Health and that securities were developed for the public with only articles.”
Below is the full text of the statement.
[성명] The government should transparently disclose and evaluate the results of clinical trials for Celltrion treatment.
Celltrion announced on the 29th that it has completed phase 2 clinical trials of the Corona 19 antibody treatment “Recyronaju (ingredient name regdanvimab, code name CT-P59)” and submitted an application for conditional approval to the Ministry of Food and Drug Safety (MFDS). According to Celltrion, a total of 327 patients participated in this phase 2 clinical trial in Korea, Romania, Spain, and the United States, claiming that they have secured sufficient evidence for the conditional application. Accordingly, the Ministry of Food and Drug Safety announced that it aims to complete the permit review in 40 days by shortening the existing permit review processing standard of 180 days. Celltrion’s Rekironaju will become the world’s first new drug for COVID-19 antibody treatment, unlike treatments in Eli Lilly and Regeneron, which are approved for emergency use in the United States if approved by the Ministry of Food and Drug Safety. This drug is administered intravenously for 90 minutes and is primarily administered to mild and moderate levels of COVID-19 patients who do not require oxygen therapy.
This remedy has been receiving media attention for a long time. Public research funds, including the Korea Centers for Disease Control and Prevention, are administered, and the project is jointly researched by the National Institute of Health, and the public is also interested in that it is a product of Korea’s leading bio-pharmaceutical company. However, in this process, there will be a need to resolve the inconvenient point of the progress, along with some concerns about whether the drug’s safety and effectiveness are missing.
First of all, unlike the noisy reaction of Rekironazu, no data on known clinical effects have been disclosed. In general, new drugs are verified by academia by publishing clinical trial results in academic journals. In particular, it has been customary to publish the results of clinical trials supported by public funds in academic journals that are free of charge, and to disclose all clinical trial results data. The effectiveness and stability of new drugs cannot be evaluated through unilateral promotion of pharmaceutical companies, and it is international common sense to maximize the transparency of the new drug R&D process and result reporting. Nevertheless, according to Celltrion’s announcement,’Detailed clinical data related to the safety and efficacy of CT-P59 has been decided to be kept private until further instructions are provided at the request of the Ministry of Food and Drug Safety.’ It is hard to believe the news that the Ministry of Food and Drug Safety has blocked the disclosure of data, as it would be insufficient even if the permitting authorities enforced public verification by various experts.
The Ministry of Food and Drug Safety has been pointed out several times in the past because it does not require public verification of clinical trials. In 2011, Korea boasted that it developed the world’s first stem cell therapy, but in Nature, a renowned academic journal,’Public officials related to the Ministry of Food and Drug Safety claim to have screened according to international standards, but foreign experts are concerned that the Korean Food and Drug Administration seems too hasty in the approval process. ‘In the case of stem cell treatments licensed in Korea, peer-review papers (which can be called an important verification procedure) are hardly found, and most of them are published in public relations articles from the Ministry of Food and Drug Safety and related ministries. There has been a criticism that most of the information is by ‘ And the world’s first stem cell therapy drug is currently rarely used for licensed purposes, and is only used illegally as a panacea at some opening prices. In such a situation where the closure and fairness of the procedure are questioned, it is difficult to trust the effectiveness of the new drug even if it is approved. Even taking into account the short permit review period, the necessary procedures must not be skipped. If passed through this process, other countries will have no choice but to look at South Korea’s permit with suspicion.
Second, Rekkironaju is a public medicine that has received enormous support from the government. In addition to supporting R&D costs and clinical trial costs, clinical trials are conducted to shorten the period of recruitment of patients for clinical trials of 2-3 years, approval of clinical trial plans that usually take 6 months to 1 year, enormous administrative support required for approval. This is the result of public R&D in which considerable public funds have been invested, such as consortium establishment (government funding) and linkage support. According to the general conditions and special conditions of the KCDC service contract, the KCDC’s authority over the relevant R&D results is also clearly stated. A pre-approval procedure for utilization of research results is also being prepared and operated. Nevertheless, so far, the people do not know anything about this development process.
What the people want is a safe and effective domestic COVID-19 treatment. It should not be forgotten that the demand for transparency about clinical trial results is the basic right of the people to receive safe and effective treatment. The government should immediately and transparently disclose information and guarantee the legitimate rights of the people. The reporter briefing by the head of the National Institute of Health and the fact that securities were developed for the public with only articles should not be told to believe in the effectiveness and safety of the treatment.
In addition to Rekirona, several COVID-19-related therapeutic and vaccine candidates are being developed through huge public taxes, public research personnel, and institutional support. The government should clarify that medicines developed specially during the Corona 19 crisis are different from those in the past, and take measures to enable medicines to play a role as a public good.
December 31, 2020
Pharmaceutical society for a healthy society
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