Celltrion corona treatment verification team recommends “Phase 3 prerequisite permission”

[사진=식약처 김상봉 바이오생약국장이 18일 충북 청주시 질병관리청 브리핑실에서 셀트리온 코로나19 치료제 검증 자문단 회의 결과를 발표하고 있다. 뉴스1]
Celltrion’s antibody treatment,’Rekironaju’, has entered verification for approval as a treatment for Corona 19. The verification advisory group proposed to grant product approval on the premise of conducting a phase 3 clinical trial.

The Ministry of Food and Drug Safety held a meeting of the’Corona Treatment/Vaccine Safety and Effectiveness Verification Advisory Group’ (hereinafter referred to as verification advisory group) on the 17th, asking for advice on the effectiveness and safety of Rekirona.

Eight external experts in the field of clinical trials, including infectious medicine specialists, virology specialists, and clinical statistics specialists, participated in this verification advisory group meeting, as well as four persons including the general review team and the clinical review team of the’Corona 19 treatment approval review team’ inside the Ministry of Food and Drug Safety. .

◆ Effectiveness= Effectiveness first looked at the rate of symptom recovery. When a patient participating in the clinical trial showed severe or moderate intensity of any of the 7 corona symptoms such as fever, the time until recovery was 5.34 days for the Rekirona group, 8.77 days for the placebo group, and the administration group. It was confirmed that it recovers quickly in 3.43 days. The verification advisory group judged that “this is statistically significant and clinically significant.”

However, there was no significant difference between the administration group and the placebo group in the’virus negative transition time’ for the virus to be converted from positive to negative.△The reduction in the proportion of patients requiring hospitalization and oxygen treatment is difficult to draw a definite conclusion, so it is necessary to judge in phase 3 △ Both the administration group and the placebo group had no deaths, so the effect on the mortality rate was unknown.

◆ Safety= About the abnormal cases such as hypertriglyceridemia and hypercalcemia that occurred from the time the drug was administered until 28 days had elapsed, the verification team revealed that it was a predictable case already confirmed in Phase 1. In addition, it was reported that there were no serious, life-threatening cases, and the rates of adverse events between the administration group and the placebo group were similar.

He said that there was almost no itching or pain caused by intravenous injection, a method of administering drugs into the body.

◆ Total = In synthesizing the above opinions, the verification advisory group requested that Rekkironaju approve the item on the premise of conducting a phase 3 clinical trial, but to follow some recommendations.

The verification team said that Rekyronaju is △People whose oxygen saturation exceeds 94% in indoor air △People who do not need supplemental oxygen supply △People who developed symptoms within 7 days prior to administration, etc. It was considered to improve clinical symptoms.

However, in the phase 3 clinical trial, it was recommended to confirm whether it significantly reduces the severity of mild and moderate to severe morbidity in sufficient patients, and to establish specific guidelines for clinical field use by discussing with related institutions separately. In addition, it was requested to conduct a separate clinical trial for patients who need adjuvant oxygen therapy in combination with THIS DRUG and conventional severe treatment or other immunomodulatory agents.

The Ministry of Food and Drug Safety is planning to decide whether to approve COVID-19 treatment after consulting the Central Pharmacy Council and the Final Inspection Committee after collecting this opinion from the verification advisory group.

Reporter Moon Se-young [email protected]

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