Celltrion’s Corona 19 antibody treatment,’Rekironaju’, has crossed the first gateway for marketing.
The Ministry of Food and Drug Safety announced on the 18th that it had recommended conditional product approval to Rekkirona as a result of a meeting of the verification advisory group for Corona 19 treatment and vaccine.
The Ministry of Food and Drug Safety finally approves the product permission of Rekkirona, receiving advice from three organizations, including the Verification Advisory Group, the Central Pharmacy Review Committee, and the Final Inspection Committee. The first step, the verification advisory group, consists of 8 external experts in the field of clinical trials, including infectious medicine specialists, virology specialists, and clinical statistics specialists, and an internal approval review team of the Ministry of Food and Drug Safety. On the 17th, the verification advisory group held a meeting of the’Corona 19 treatment/vaccine safety/effectiveness verification advisory group’ and reviewed the effectiveness and safety of Rekirona.
They judged the therapeutic effect of the drug using two indicators. First of all, the clinical effectiveness measurement index, which measured the time it takes for all seven corona19 core symptoms to improve, was evaluated. As a result of the test, the average time it took for the Rekirona injection group to recover was 5.34 days, which was 3.43 days earlier than the placebo group (8.77 days).
However, there was no significant difference between the placebo group and the receiving group in the time required for negative warfare, another indicator. The time required for negative transfer is the time to convert from positive to negative as a result of a virus test, and refers to the time it takes to actually’cure’. The verification advisory group revealed that there is no standardized virus measurement method and there is no significant clinical significance due to the large variation between test results.
It was confirmed that there were no serious abnormal cases in terms of safety. The Ministry of Food and Drug Safety observed abnormal cases that occurred from the time the drug was administered until 28 days had elapsed. As a result, no serious abnormalities were found other than hypertriglyceridemia and hypercalcemia identified in phase 1 clinical trials.
The verification advisory group conveyed the opinion that product approval should be performed on the premise of conducting phase 3 clinical trials for Rekirona. However, it was recommended that patients with mild and moderate symptoms should further confirm in phase 3 clinical trials whether they significantly reduce the worsening to severe. Kim Sang-bong, head of the Bio-Pharmaceutical Bureau of the Ministry of Food and Drug Safety, said at a briefing on the day, “We plan to receive advice on safety and effectiveness from the Central Pharmacy Review Committee, the legal advisory body of the Ministry of Food and Drug Safety, by integrating expert opinions and recommendations obtained through the verification advisory group meeting.” Revealed. The Ministry of Food and Drug Safety announced last month that it will shorten the approval process for the Corona 19 treatment and process it within 40 days.
Reporter Jiwon Choi [email protected]
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