The Ministry of Food and Drug Safety announced that it would thoroughly verify the efficacy and safety of Celltrion’s antibody treatment drug’Regdanvimab (ingredient name regdanvimab, developed name CT-P59)’ through a triple consultation procedure.
The Ministry of Food and Drug Safety said on the 14th, announcing a plan for consulting external experts to secure objectivity and transparency in the approval of a new coronavirus infection (Corona 19) treatment and vaccine.
In accordance with the Pharmaceutical Affairs Act, the Ministry of Food and Drug Safety operates the’Central Pharmacy Review Committee’ on matters related to the safety and effectiveness of newly used drugs, and is undergoing a procedure to seek advice.
In addition to this, the Ministry of Food and Drug Safety has additionally formed the’Corona 19 Treatment/Vaccine Safety/Effective Verification Advisory Group’ and’Final Inspection Committee’ in consideration of the severe situation of the Corona 19 pandemic to implement a triple advisory procedure. I will go through it. Accordingly, consultation will be conducted in the order of verification advisory group → central pharmacy review committee → final inspection committee.
First of all, the’Verification Advisory Group’ is a procedure to collect advisory opinions on areas such as clinical, non-clinical, and quality from various experts before consulting the Central Pharmacy Review Committee. The Ministry of Food and Drug Safety is a clinical expert, non-clinical, quality, and A pool of experts has been formed in advance, including about 30 experts in clinical statistics, etc., and meetings of advisory groups attended by experts in the field are held according to the agenda.
The’Central Pharmacy Review Committee’ is an advisory body for the Ministry of Food and Drug Safety pursuant to Article 18 of the Pharmaceutical Affairs Act. The advisory committee consists of about 15 people, including standing members of the Biological Drug Subcommittee and related experts, and advises on matters discussed in the verification advisory group and clinical usefulness. It is a specialized subcommittee for deliberation on matters.
Lastly, prior to the final approval decision, the Ministry of Food and Drug Safety holds a’final inspection committee’ in which internal and external experts (around 10 people) participate in joint participation, and conducts a final inspection based on the results of consultations with the verification advisory group and the Central Pharmacy Review Committee.
Accordingly, the Ministry of Food and Drug Safety will hold a meeting of the’Verification Advisory Group’ on the clinical trial data of Celltrion’Recyronaju’ on the 17th, and the results will be disclosed on the 18th.
The Ministry of Food and Drug Safety plans to receive advice at the verification advisory group meeting on whether the clinical results of the indicators for measuring the clinical effectiveness and the indicators for measuring the principle of operation of the drug used in the clinical trial of’Rekironaju’ are appropriate to acknowledge the therapeutic effect of this drug. to be.
The Ministry of Food and Drug Safety said, “We will collect various expert opinions in the process of reviewing the approval of COVID-19 treatments and vaccines to ensure objectivity and transparency, while making efforts to ensure thorough approval and review.”
On the other hand, Celltrion released the results of the Phase 2 clinical trial of’Rekironaju’ on the 13th. Professor Eom Joong-sik of the Infectious Medicine Department at Gil Hospital, Gachon University, who led the clinical trial and announced the results on the same day, said, “Reckironaju reduced the severe progression in patients with mild to moderate corona19 by more than half, and also reduced hospital stay for patients hospitalized with moderate illness. It is expected that it will be able to help reduce the burden on medical institutions by shortening it.”