Kang-rip Kim, the head of the Ministry of Food and Drug Safety, is giving a briefing on the 5th to decide on the approval of Celltrion’s Corona 19 antibody treatment drug’Rekironaju’.
[Chungbuk Ilbo] The Ministry of Food and Drug Safety decided to grant permission for the Corona 19 antibody treatment’Recyronaju 960mg (Regdanvimab)’, which Celltrion Co., Ltd. applied for permission, subject to the submission of the results of the phase 3 clinical trial.
The decision was made 39 days after Celltrion applied for permission on December 29 last year.
‘Rekironaju’ is a gene recombination neutralizing antibody treatment that selects the neutralizing antibody gene present in the blood of a cure for Corona 19, inserts (recombines) this gene into a host cell capable of mass production, and produces it in mass through bagging culture. .
Efficacy/effect is the improvement of clinical symptoms in patients with mild to moderate corona19 (18 years of age or older) in high-risk groups.
As for the usage and dosage, about 40 mg per 1 kg of adult body weight is injected intravenously for 90 minutes (±15 minutes).
‘Rekironaju’ is the first corona 19 treatment approved as a domestically developed drug, and the third corona 19 antibody treatment approved by regulatory authorities in the world.
The Ministry of Food and Drug Safety expects that if Leckirona is used in medical fields, it will play a meaningful role in overcoming Corona 19 and recovering it to daily life along with a vaccine to be used in Korea in the future. If a clear effect is confirmed in a phase 3 clinical trial, it is expected to be used not only for patient treatment, but also to relieve difficulties such as securing critically ill beds in quarantine and medical fields.
The Ministry of Food and Drug Safety conducted a review based on scientific grounds, putting safety first after receiving the application for the product license for Rekkirona.
On January 17th, we received advice from the verification advisory group on whether the results of the Rekirona state clinical trial were appropriate to acknowledge the therapeutic effect of this drug and the safety of the drug.
On the 27th of the same month, the Central Pharmacy Review Committee was consulted on whether it would be appropriate to acknowledge the safety and effectiveness under the condition of submitting the results of the phase 3 clinical trial after marketing.
The Ministry of Food and Drug Safety plans to manage the phase 3 clinical trials faithfully even after the product is approved.
The company plans to cooperate with relevant ministries so that it can be thoroughly monitored for side effects in the use process and used safely for patients in need in clinical settings.
/ Reporter Kang Joon-sik [email protected]