[비즈헬스] Celltrion’s corona 19 treatment’Rekironaju’ approval is imminent… Opinion that approval is possible under the premise of Phase 3

[비즈월드] The approval of Celltrion’s Corona 19 antibody treatment “Reekyronaju (ingredient name Regdanvimab)” is imminent.

The Ministry of Food and Drug Safety announced on the 27th that the Central Pharmacy Review Committee, which is a legal advisory body, has issued an opinion that it can approve Rekkirona on the premise of a phase 3 clinical trial. However, there was a condition that the group of patients receiving Rekirona should be partially restricted.

On this day, the committee proceeded to seek advice from experts on the safety and effectiveness of Rekkirona. A total of 24 people participated in the meeting, including 18 external experts and 6 internal employees of the KFDA.

They concluded that the Ministry of Food and Drug Safety could approve the product subject to Celltrion’s submission of the results of a phase 3 clinical trial of Rekirona. This conclusion is the same opinion as the recommendation of the’Corona 19 Treatment and Vaccine Safety and Effectiveness Verification Advisory Group’ last week.

The committee explained that it was the result of comprehensive consideration of the corona 19 pandemic situation in Korea, patient access to Corona 19 treatment, and the choice of medical staff after reviewing the safety and effectiveness of Rekkirona based on the data submitted by Celltrion.

However, the Committee decided that it was difficult to judge the clinical effects of Rekirona in mild patients. As a result of the phase 2 clinical trial of Rekirona, a statistically significant level of therapeutic effect was not found in patients with mild symptoms, so it was recommended to limit the group of patients administered.

This suggests that Rekirona should be administered to patients with mild and moderate symptoms in high-risk groups. In addition, all three conditions must be satisfied: ▲ those whose oxygen saturation exceeded 94% in the indoor air ▲ those who do not need supplemental oxygen supply ▲ those who developed symptoms within 7 days before administration.

The Ministry of Food and Drug Safety is planning to decide whether to approve the state of Rekkirona through the final inspection committee, the last expert advisory procedure. It is said that the current conditional license is being caught.

An official from the Ministry of Food and Drug Safety said, “I will decide whether to grant permission by integrating expert opinions, efficacy, effects, and recommendations obtained through consultation from the verification advisory group and the Central Pharmacy Review Committee from the final inspection committee.”