▲ Celltrion antibody treatment (Yonhap News)
The results of Celltrion’s second consultation on Corona 19 antibody treatment will be released on the 27th.
On the 27th, the Ministry of Food and Drug Safety, the statutory advisory body,’Central Pharmacy Deliberation Committee’, on the data of the Phase 2 clinical trial of the corona 19 antibody treatment’Recyronaju’ (ingredient name Legdanvimab CT-P59) for which Celltrion applied conditional permission ‘And announced on the 21st that the results will be released on the same day.
The Ministry of Food and Drug Safety conducts a three-fold consultation process before approving Corona 19 vaccines and treatments, including △Verification Advisory Group, △Central Pharmacy Review Committee, and △Final Inspection Committee. At the verification advisory meeting announced on the 18th prior to the consultation of the Central Pharmacy Review Committee, the effectiveness of Rekkirona was recognized, but it was determined that additional verification was necessary, and conclusively, conditional approval was recommended to the Ministry of Food and Drug Safety.
On the 20th, the Ministry of Food and Drug Safety requested Celltrion to submit data on some of the quality data that have not yet been submitted in relation to Rekirona, and the review will continue as soon as it is submitted. Afterwards, the’Central Pharmacy Review Committee’ is consulted on the safety, effectiveness, and matters to be considered for approval on the 27th by synthesizing the review results.
On the other hand, prior to consultation, the Ministry of Food and Drug Safety checks the status of clinical trial institutions (medical institutions) for 4 days from 12 to 15 days, such as the safety of clinical trial subjects and reliability of test results. It was confirmed through investigation and document review.
▲ A novel coronavirus infection (Corona 19) vaccine jointly developed by Oxford University in the UK and AstraZeneca. (Reuters Yonhap News)
The AstraZeneca Corona 19 vaccine verification advisory group meeting will be held on the 31st.
The Ministry of Food and Drug Safety announced that the’Corona 19 Vaccine Safety and Effectiveness Verification Advisory Group’ meeting will be held on the 31st, with external experts participating in the clinical trial data for the’AstraZenecacovid-19 vaccine strain’ applied by AstraZeneca Korea. . The results of the meeting will be released on February 1.
The advisory group is composed of clinical experts focusing on infectious medicine, non-clinical, and external experts with extensive expertise and experience in the field of quality, and will consult on the safety and effectiveness of the applied item, clinical significance, and appropriateness of the target patient.
Previously, the Ministry of Food and Drug Safety completed an investigation into the factory regarding the AstraZeneca Corona 19 vaccine. Since then, on the 14th, additional data necessary for examination, such as non-clinical and clinical test data and quality data, were requested. As soon as the data were submitted, the prevention effect, the validity of the applied dosage and administration, and safety were reviewed, and We will focus on the quality field review.