Food and Drug Administration, expert advisory group meeting
Recommend the necessity of confirming the effect of Celltrion Rekirona
[서울=뉴스핌] Reporter Jeong Seung-won = Experts recommended that Celltrion’s new coronavirus infection (Corona 19) treatment, Rekirona, needs to be further confirmed for its effect on reducing morbidity from severe morbidity in phase 3 clinical trials.
The Ministry of Food and Drug Safety held a meeting of the’Corona 19 treatment/vaccine safety/effectiveness verification advisory group’ (verification advisory group) meeting on the 17th of the clinical trial results of Trion’s antibody treatment’Rekironaju’, and the results were reported on the 18th. Announced.
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| [인천=뉴스핌] Reporter Jeong Il-gu = On the afternoon of December 22, the Celltrion novel coronavirus infection (Corona 19) antibody treatment’CT-P59′, which is undergoing clinical trials at Celltrion Plant 2 in Yeonsu-gu, Incheon, is being released. 2020.12.22 [email protected] |
The verification advisory group is a procedure for the Ministry of Food and Drug Safety to collect advisory opinions on areas such as clinical, non-clinical, and quality from various experts prior to consulting the Central Pharmacy Review Committee. Eight experts from outside the field, the general review team of the’Corona 19 treatment approval review team’ inside the KFDA, and the clinical review team attended.
At the meeting, we received a fingerprint on the safety and whether the results of the clinical trial of Rekironaju were adequate to acknowledge the therapeutic effect of this drug.
In particular, we were consulted on whether the clinical results of the clinical efficacy measurement index used in the clinical trial of Rekirona and the principle of operation of the drug were appropriate to acknowledge the therapeutic effect of this drug.
In clinical trials, in order to confirm that patients who received Rekirona injection were actually quickly recovering from the symptoms of Corona 19 and were clinically effective, at the time the patient participated in the clinical trial, even one of the 7 corona 19 symptoms was severely Or the drug was administered when it appeared moderately.
Through this, the intensity of all symptoms was observed for up to 14 days twice a day after receiving Rekironaju or placebo, and the time required until it was determined that all 7 symptoms disappeared or weakened, and until recovery from Corona 19 symptoms. It was confirmed that the time taken was 5.34 days for patients receiving THIS DRUG and 8.77 days for patients receiving placebo.
The verification advisory group said, “It is statistically significant that the time to improve the symptoms of Corona 19 has decreased by administering this drug, which is clinically significant.”
It was also confirmed that there was no significant difference in the time to transition from positive to negative as a result of the virus test (the time required for negative conversion of the virus) between patients taking Rekirona and those who did not.
Regarding this, the advisory group explained, “It is not statistically significant that the time to transition from positive to negative as a result of the virus test is not statistically significant, but a tendency to decrease the virus concentration in the body was observed after administration of this drug.”
Because the virus measurement method is not standardized and the test method itself has a large variance between test results, the result of the time required for virus negative transduction is not clinically significant.
In this clinical trial, observation was conducted from the time of administration to the point of time 28 days had elapsed to determine if the rate of occurrence of patients requiring hospitalization and oxygen therapy decreased when receiving THIS DRUG as an auxiliary method to confirm the effect. .
The verification advisory group said, “There was a tendency that the proportion of patients who were hospitalized or need oxygen therapy due to COVID-19 by administering drugs tended to decrease, but at the stage of clinical trial planning, a separate statistical test method was not established for this item, and as of now, a clear conclusion was drawn. It is difficult” he said.
The advisory group added, “The proportion of patients who need hospitalization, oxygen therapy, etc. needs to determine the specific results and meaning through a phase 3 clinical trial that will be conducted for many patients in the future.”
The advisory group combined these and confirmed that the reduction of mild, moderate to severe morbidity in a sufficient number of patients in the phase 3 trial of Rekyrona ▲Preparation of separate specific guidelines for clinical use ▲Supplementary oxygen therapy A separate clinical trial was ordered for patients in need of this drug and conventional severe treatment or other immunomodulatory drugs.
The Ministry of Food and Drug Safety examines the expert opinions, efficacy, and recommendations obtained through this advisory group meeting, as well as the submitted materials, and aggregates the results to advise the Central Pharmacy Review Committee on the safety, effectiveness, and matters to be considered during approval. I plan to receive.