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| On the 5th, the head of the Ministry of Food and Drug Safety, Kim Kang-rip, is giving a briefing for the approval of Celltrion’s Corona 19 antibody treatment,’Rekkironaju’ at the briefing room of the Ministry of Food and Drug Safety in Osong-eup, Cheongju-si, Chungbuk. 2021.2.5/News1 © News1 Reporter Jang Soo-young |
Celltrion’s novel coronavirus infection (Corona 19) antibody treatment,’Reckironaju’, received conditional approval from the Final Inspection Committee of the Ministry of Food and Drug Safety on the 5th, and is prescribed for mild and moderately ill patients aged 18 years or older. With this, Rekironaju was the first domestically produced and the world’s third corona19 antibody treatment title.
According to the Ministry of Food and Drug Safety on the 6th, there is a possibility that the prescription for Rekkironaju will begin before the Lunar New Year holidays. In a briefing on the 5th, the head of the Food and Drug Administration said, “Celltrion has already completed production, and if there is demand in the clinical field, it will be able to be used in the field in the shortest time.” Celltrion previously revealed that it has produced 100,000 prescriptions.
The target group for Rekirona’s treatment is high-risk mild-to-moderate corona19 confirmed patients over the age of 18. The Ministry of Food and Drug Safety expected that Rekirona would curb a more severe disease, a severe disease. However, research on the therapeutic effect of the mutant virus, which is growing in concern recently, is still underway at home and abroad, and it plans to respond further when the results are released.
◇For high-risk patients with mild or moderate illness… Expected to reduce severe morbidity
This conditional approval was obtained based on the phase 2 clinical trial of Rekirona. Celltrion must proceed separately for Phase 3 clinical trials and submit the results. Celltroon has already started phase 3 clinical trials targeting 1172 mild and moderately ill patients in 10 countries around the world.
The Ministry of Food and Drug Safety’s Final Inspection Committee confirmed the scope of treatment for Rekirona to be patients with mild to moderate symptoms in the high-risk group over 18 years old. High-risk patients with mild symptoms are those aged 60 or older or 18 years of age or older and have an underlying disease. Patients with moderate illness are those with symptoms of pneumonia. Director Kang-rip Kim said, “The effect of reducing severe morbidity can be expected due to the indication of Rekirona.”
In addition, it is expected that general mild patients can be prescribed according to the judgment of the medical staff. “Since there is a system that can be used according to clinical judgment in the medical field, there is room for use if there is a judgment by the medical staff that it is also necessary for general mild patients,” said Kim Gang-rip, chief of staff.
◇Celltrion, Rekirona production completed for 100,000 people… Prescribe if requested on site
Rekironaju can be prescribed from 2:00 p.m. on the 5th when the final inspection committee announced conditional approval. Celltrion completed the production of Rekironaju, which can be used by 100,000 patients last year.
Since the preparation for the prescription is almost finished, it is expected that the prescription for Rekirona can be made as early as before the Lunar New Year holidays.
Director Kang-rip Kim said, “After permission, the Korea Centers for Disease Control and Prevention (KCDC) has already prepared a plan to use (Rekirona) first, and we expect to proceed with the procedure for applying health insurance in detail.”
An official from Celltrion said, “We will do our best to supply Rekirona to the whole country as soon as possible to significantly accelerate the treatment period for Corona 19 for the Korean people and minimize the occurrence of severe patients that can lead to death.”
◇ Is it effective for mutant viruses? Concerned about side effects?… Disease Administration “Under research, check the results next week”
However, Rekironaju has not yet had a therapeutic effect on the COVID-19 mutant virus from the UK and South Africa, which is spreading worldwide recently.
Some have also raised the opinion that antibody treatments can cause side effects that increase the infectivity of mutant viruses.
In an online discussion held by the Korea Science Journalists Association on the 2nd, the head of the Center for Central Infectious Diseases Hospital Operation Center at the National Medical Center said, “If the structure of the spike protein changes due to the mutation of the Corona 19 virus, neutralizing antibodies ambiguously bind to the mutant virus and penetrate cells. And can help multiply.”
“Currently, the Agency for Disease Control and Prevention and Celltrion are jointly testing whether they have an effect on mutations in the UK or South Africa,” said Kim. “Research on (mutant virus) is being conducted not only in Korea but also in leading research institutes in the US, UK, France, etc. “I understand that it is being done.” He added, “According to the results, we will respond if necessary measures are requested.”
Kim said, “There are still few cases of spreading the mutant virus in Korea, and the six gene types that have been prevalent in Korea have been verified.” “If the results of the National Institute of Health Research and meaningful foreign research are submitted, we will make the necessary judgments accordingly.”
According to the quarantine authorities, a total of 39 cases of domestic mutant virus were found as of the last day. Of these, there were 27 mutations from the UK, 7 mutations from South Africa, and 5 mutations from Brazil. According to the city of Busan, two additional cases of mutant virus in South Africa were confirmed on the 5th.
On the 4th, the Agency for Disease Control and Prevention said on the 4th, “We are currently conducting related experiments on antibody treatments.”