Reporter Seo Yoon-Seok, Bio Spectator
Product approval is recommended under the premise of performing Phase 3 of the’Corona 19 treatment/vaccine safety and effectiveness verification advisory group (verification advisory group)’.. Final decision on product approval after the Jungyang Pharmacy Review Committee and the final inspection committee is scheduled
At a meeting of the’Corona 19 Treatment/Vaccine Safety and Effectiveness Verification Advisory Group (verification advisory group)’, the Ministry of Food and Drug Safety recommended product approval on the premise of conducting phase 3 clinical trials for Celltrion’s Corona 19 antibody’Rekironazu’.
The verification advisory group meeting is a procedure in which the Ministry of Food and Drug Safety collects advisory opinions on areas such as clinical, non-clinical, and quality from various experts before consulting the Central Pharmacy Review Committee.
The advisory phase of the COVID-19 treatment and vaccine approval review takes place three times, and the approval of the item is finally decided after receiving the advice of the verification advisory group and the central pharmacist review committee.
Kim Sang-bong, head of the Food and Drug Administration’s Bio-Pharmaceutical Bureau, announced the results at an online briefing on the status of the Corona 19 treatment and vaccine approval status, which began at 3:10 pm on the 18th.
The Ministry of Food and Drug Safety announced that the clinical results on the’Clinical Effectiveness Measurement Index’ and the’Measurement Index of the Principles of Drugs’ regarding the effectiveness of Rekirona at the verification advisory meeting held on the 17th were appropriate to acknowledge the therapeutic effect of Rekirona. I was consulted on the paper.
The verification advisory meeting was attended by eight external experts in the field of clinical trials, including infectious medicine specialists, virology specialists, and clinical statistics specialists, 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.
As a result, the verification advisory group determined that the time until the symptoms of Corona 19 recovered from the clinical effectiveness measurement index was significantly reduced by 3.43 days and was clinically significant. There was no significant difference in the time to transition from positive to negative as a result of the virus test in the measurement index of the drug’s operating principle, but it was judged that there was no significant clinical significance. Because there is a limitation of the test method itself that there is a large deviation between test results.
In addition, as a result of checking whether the incidence of patients requiring hospitalization or oxygen therapy decreases as an auxiliary method for confirming the effectiveness of the drug, the proportion of patients who need hospitalization or oxygen therapy showed a tendency to decrease, but later phase 3 It was determined that further analysis was necessary.
As a result of confirming the abnormal cases that occurred up to 28 days after administration of Rekirona, the verification advisory group revealed that most of the cases were mild or moderate, but there were no serious adverse reactions that threatened life at a level similar to that of the placebo group.
In addition, he explained that hypertriglyceridemia and hypercalcemia that occurred after drug administration were already confirmed in a phase 1 clinical trial and were predictable abnormal cases.
Summarizing these results, the verification advisory group is △People whose oxygen saturation exceeds 94% in indoor air △People who do not need supplementary oxygen supply △People who developed symptoms within 7 days prior to administration, etc. It was recommended to have the effect of improving clinical symptoms for patients with Corona 19.
Subsequently, the verification advisory group will confirm that △Sufficient numbers of patients in the phase 3 clinical trial significantly reduce the risk of mild-moderate to severe morbidity △Concerning clinical field use, specific guidelines will be discussed separately with related organizations. △ It was recommended that patients in need of supplemental oxygen therapy conduct a separate clinical trial in combination with Rekyrona and existing severe treatments or other immunomodulators.
The Ministry of Food and Drug Safety is planning to review the submitted data, including expert opinions, efficacy effects and recommendations obtained through the verification advisory group’s advisory meeting, and some of the quality data still remaining. In addition, by summarizing the results, it was announced that the’Central Pharmacy Review Committee’, a legal advisory body of the Ministry of Food and Drug Safety, plans to receive advice on the safety, effectiveness, and matters to be considered when licensing.
(Refer to the KFDA announcement)