Celltrion’s new coronavirus infection (Corona 19) antibody treatment drug’Recyronaju’ (ingredient name Regdanvimab CT-P59) will be conditionally approved on the 5th. / Photo = Yonhap News
On the 5th, it will be announced on the 5th whether the conditional approval of Celltrion’s novel coronavirus infection (Corona 19) antibody treatment drug’Recyronaju’ (ingredient name Regdanvimab CT-P59) will be announced.
The Ministry of Food and Drug Safety will hold a final inspection committee at 10 am on the day to determine whether to approve or not by integrating expert opinions, efficacy, effects, and recommendations for Rekkirona. The results will also be released on this day.
If the conditional approval decision falls, the first Korean-made Corona 19 treatment will be born. By global standards, it is the third antibody treatment after Eli Lilly and Regeneron, a multinational pharmaceutical company.
Corona 19 drugs go through a’triple’ external expert advisory procedure, such as the Verification Advisory Group, the Central Pharmacist Review Committee (Central Pharmacy Review), and the Final Inspection Committee meeting before approval. The consultation of the final inspection committee on this day is the last step.
Previously, the verification advisory group recommended product approval on the premise of performing phase 3 clinical trials of Rekirona.
As a result of the phase 2 clinical trial, the recovery time for COVID-19 patients treated with Rekirona was 5.34 days and 8.77 days in the placebo group. The advisory group meant that the Corona 19 patients who were administered Rekironaju recovered as quickly as 3.43 days.
However, the advisory group did not confirm statistical significance with respect to the time for Rekirona to convert the virus from positive to negative (the time required for negative conversion of the virus) and found that the effect on the mortality rate was unknown.
The Central Pharmacopoeia also recommended product approval under the condition of submitting the results of phase 3 clinical trials, but it was believed that Rekirona should be administered only to patients with mild and moderate symptoms in high-risk groups. This is because, as a result of phase 2 clinical trials, a statistically significant level of treatment effect was not confirmed in mild patients.
Shin Hyun-ah, reporter at Hankyung.com [email protected]
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