The Ministry of Food and Drug Safety announced on the 29th of last month that it has initiated a license review for Celltrion’s new coronavirus infectious disease (Corona 19) antibody treatment,’Rekironaju’. Celltrion applied for permission from the Korean Food and Drug Administration, and at the same time initiated procedures to obtain emergency use approval in the United States and Europe. The photo shows the cure that was released to the media on the 22nd of last month.[사진=연합뉴스]
According to the pharmaceutical and bio industry on the 5th, Celltrion decided to participate in the 2021 High1 New Drug Development Symposium hosted by the Korean Pharmacy Society on the 13th of this month and announce the results of the global clinical phase 2 of Rekkirona.
Earlier, Celltrion applied for conditional approval to the Korean Ministry of Food and Drug Safety after completing Phase 2 of Rekkirona’s global vision, but did not disclose detailed clinical data.
This is because the Ministry of Food and Drug Safety has agreed to keep the data private until there is a separate guideline, taking into account the public’s focus on COVID-19 treatment.
However, despite the fact that the introduction of the domestic Corona 19 treatment was made visible, it was decided to announce it early as concerns emerged as no clear clinical results were revealed.
Celltrion said, “The company and the Ministry of Food and Drug Safety have been in close consultation with the early disclosure of clinical data.”
In addition, a Celltrion official said, “Rekirona is expected to prove the initial treatment effect that the company has been talking about by remarkably lowering the rate of development of severe patients when administered to mild and moderate corona19 patients.”
Celltrion plans to announce the results of phase 2 clinical trials of Rekirona at an international conference soon.
Phase 2 clinical trials were conducted in 327 mild and moderate corona19 patients in Romania, Spain, and the United States along with Korea. On November 25, last year, the final medication was completed, and on December 29, it applied for conditional permission from the Food and Drug Administration. Apart from the conditional approval, Celltrion will also enter phase 3 clinical trials in 10 countries around the world.
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