Blood samples collected at the end of February last year… The KFDA approved 38 days after application
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After one year of development, the first domestic novel coronavirus infection (Corona 19) treatment was born. As the third corona19 antibody treatment approved by health authorities in the world, Korea became the second country to develop a corona19 antibody treatment after the United States.
On the 5th, the Ministry of Food and Drug Safety made a decision to grant permission for Celltrion’s’Rekkironaju’ (ingredient name regdanvimab CT-P59) on the condition of submitting phase 3 clinical data. Celltrion completed the discovery of candidate substances, animal tests, and phases 1 and 2 clinical trials within one year, and proved the safety and effectiveness of Rekirona. It is a different method from’drug re-creation’, which changes the use of drugs used to treat other diseases. As a result, Rekkironaju also won the title of’Domestic No. 32 New Drug’.
Celltrion began collecting blood samples from recovering patients on February 27, one month after the first confirmed case in Korea in January of last year. In April, after confirming the final antibody candidate group with high’neutralizing ability’ that lowers viral infectivity, it started developing cell lines. After completing the efficacy and toxicity tests in animals with the developed cell line, from July, it began a phase 1 clinical trial on 32 healthy people and 9 patients with mild Corona19 to confirm its safety and effectiveness. In September, Phase 2 and 3 clinical trials were simultaneously administered to patients with mild and moderate Corona 19, and then, a total of 327 patients were administered in Romania, Spain, and the United States. I did it.
The government’s rapid approval review procedure also played a part in accelerating the birth of a new Korean drug for Corona 19. Although it usually takes about 6 months for drug approval, the Ministry of Food and Drug Safety has set a goal to shorten it as much as possible for COVID-19 treatments and vaccines, and to process them within 40 days. Accordingly, Rekironaju was approved quickly after 38 days of filing an application on December 29 last year. The Ministry of Food and Drug Safety carefully reviewed the state of Rekkirona through preliminary review, screening, and three expert advisory meetings over a period of a little over a month.
After the announcement of the results of phase 2 clinical trials, Rekironaju was also controversial that there was no statistical significance in the time at which the virus was converted to negative (virus negative time). In addition, there was an expert diagnosis that the neutralizing antibody made by Rekironaju could ambiguously bind to the mutant virus and help infiltrate the cells, so it could have an adverse effect. However, the Ministry of Food and Drug Safety determined that the main data necessary for the permit review were faithfully submitted and that there was no problem with safety and effectiveness.
Celltrion is planning to secure statistical significance of Rekirona by entering phase 3 clinical trials of Rekirona with 1,172 mild and moderately ill patients in 10 countries around the world.
/ Intern reporter Hyein Lee [email protected]
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