Celltrion announced results of external clinical trials

for COVID-19 tx on the 18th

The MFDS holds a verification advisory group meeting to evaluate the suitability of clinical trials on the 18th

Final Conditional Marketing Authorization (CMA) decision

The MFDS will hold a verification advisory group meeting on the 17th to evaluate the appropriateness of the clinical trial results for COVID-19 treatment Rekirona developed by Celltrion.

 

And it plans to announce the results on the 18th.

 

After the verification advisory group meeting, the Central Pharmaceutical Affairs Review Committee and the final review committee decide whether to grant CMA through internal and external verification.

 

The MFDS is currently operating the Central Pharmacy Review Committee on matters related to the safety and effectiveness of new drugs in accordance with the Pharmaceutical Affairs Law and is undergoing a procedure to seek advice.

 

Taking into account the severe situation of COVID-19 pandemic, COVID-19 Treatment/Vaccine Safety and Effectiveness Verification Advisory Group and the Final Inspection Committee were additionally formed to go through a triple consultation process.

 

The verification advisory group, the Central Pharmaceutical Affairs Review Committee, and the final review committee are in order.

 

The Verification Advisory Group is a procedure in which the MFDS collects advisory opinions such as clinical, non-clinical, and quality from various experts prior to consulting the Central Pharmaceutical Affairs Review Committee.

 

It was composed of about 30 experts in statistics, etc.

 

Depending on the agenda, an advisory group meeting will be held in which experts in the field participated.

 

The Central Pharmaceutical Affairs Review Committee is an advisory body of the MFDS pursuant to Article 18 of the Pharmaceutical Affairs Law.

 

The advisory committee consists of about 15 members, including standing members of the Biological Drug Subcommittee and related experts, and consults on matters discussed by the verification advisory group and clinical usefulness.

 

The Biologics Subcommittee is a specialized subcommittee for deliberation on the safety and effectiveness of biopharmaceuticals such as vaccines and genetically modified drugs.

 

Prior to the final approval decision, the MFDS plans to hold a'final inspection committee' in which internal and external experts (about 10 people) jointly participate, and conduct a final inspection based on the results of the verification advisory group and the'Central Pharmaceutical Affairs Review Committee .

 

The Ministry of Food and Drug Safety will hold a verification advisory group meeting on the clinical trial data of Celltrion's Rekirona on the 17th, and the results will be released on the 18th.

 

At the verification advisory group meeting, it plans to receive advice on whether the clinical results for the indicators for measuring the clinical effectiveness and the indicators for measuring the principle of operation of the drug used in clinical trial of Rekirona are appropriate to acknowledge the therapeutic effect of this drug.

 

The clinical efficacy measurement index is to evaluate how quickly the administered patient recovers from the seven symptoms of COVID-19 (fever, cough, difficulty breathing, sore throat, muscle pain, fatigue, and headache).

 

A measure of how the drug works is to evaluate how short the time between positive to negative virus test results is reduced.

 

An official from the MFDS said, "We will try to collect various opinions from experts in the process of reviewing the approval of the treatment and vaccine for COVID-19 so that a thorough approval and review can be accomplished.