COVID-19 Treatment 'Remdesivir' Approved in South Korea

[Image source=Yonhap News]

[Asia Economy Reporter Cho Hyun-ui] The novel coronavirus disease 2019 (COVID-19) treatment drug 'Remdesivir,' which has been supplied domestically through special importation, has received approval from the Ministry of Food and Drug Safety (MFDS).

Remdesivir is an antiviral drug developed by the U.S. company Gilead Sciences as an Ebola treatment, and it has been confirmed to have therapeutic effects against COVID-19. In clinical trials conducted under the leadership of the U.S. National Institutes of Health (NIH) across 73 medical institutions in 10 countries worldwide, it reduced the recovery period of COVID-19 patients by approximately 31%, from 15 days to 11 days.

On the 24th, the MFDS announced that it had approved the product license for Gilead Sciences Korea's 'Veklury' (generic name Remdesivir).

Since June, considering the urgent COVID-19 situation, the MFDS has supplied Remdesivir from this month through special import approval so that domestic patients could use it on a priority basis. As of the 21st, 76 severe patients at 27 hospitals have been administered Remdesivir.

Taking into account the prolonged global COVID-19 pandemic, its spread, and the product approval movements for Remdesivir in other countries, the MFDS decided to approve the import product license to secure a continuous and stable supply for domestic patient treatment.

This approval is conditional, based on non-clinical trial literature data and interim analysis results of clinical trials. The final results of ongoing international clinical trials, some manufacturing and quality control standard data, and additional risk mitigation measures are to be submitted post-marketing.

These conditions are at a similar level to those of regulatory authorities in Europe and Japan. Currently, Japan and Europe have also conditionally approved Remdesivir and are supplying it locally.

Gilead Sciences Korea must submit related data according to the schedule announced by the MFDS upon this approval.

Lee Eui-kyung, Commissioner of the MFDS, said, "This product approval will be an important case in establishing a pharmaceutical supply system that proactively responds when public health threats arise."

This content was produced with the assistance of AI translation services.