Celltrion researcher is testing corona antibody treatment at Celltrion 2 plant in Yeonsu-gu, Incheon. /Celltrion provided
Celltrion(322,500 +0.47%)The results of the second consultation of the Ministry of Food and Drug Safety on the anti-body treatment drug’Rekkironaju’ (ingredient name regdanvimab CT-P59) of the novel coronavirus infection (Corona 19) will be announced today.
The Ministry of Food and Drug Safety is scheduled to conduct a second deliberation at 2 pm on the 27th at the’Central Pharmacy Review Committee’ (hereinafter referred to as the Central Pharmacy Review Board), a legal advisory body, and announce the results at 5 pm.
On this day, the Central Pharmacopoeia is planning to evaluate the appropriateness of the approval recommendation opinion of the first verification advisory group on safety and effectiveness, and additional review data recently submitted by Celltrion.
Consultation on the Central Pharmacopoeia is the second step in the external expert consultation process for the approval review for COVID-19 treatment prepared by the Ministry of Food and Drug Safety as a’triple’.
The domestic COVID-19 treatment review procedure consists of’reception → preliminary review → review and fact-finding → consultation → permission’. In order to secure the objectivity and transparency of the permit review in three stages of consultation, opinions from external experts are sought in the order of the 1st verification advisory group, the 2nd central agreement, and the 3rd final review committee.
Earlier, the 1st Verification Advisory Group concluded that it recommends product approval under the condition of conducting a phase 3 clinical trial for Rekirona. This is because the time to improve and disappear from Corona 19 symptoms has been statistically significantly reduced.
In clinical practice, the symptom improvement time of patients with Corona 19 who was administered Rekirona injection was 5.34 days, which was 3.43 days earlier than in the placebo group (8.77 days). However, as a result of the virus test, the time to transition from positive to negative (the time required for virus negative transduction) has no clinical significance, and the effect on mortality was not known.
Accordingly, the Central Pharmacopoeia plans to discuss the negative consequences of the virus again, but there is an opinion that it is highly likely to issue a recommendation to approve the license under the condition of phase 3 clinical trials.
When the deliberation on the central drug review is completed, the final review committee, in which 10 internal and external experts participate, synthesizes the previous review opinions. After that, the KFDA decides whether to permit domestic approval after final review.
Reporter Chae Sun-hee [email protected]
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