MFDS Begins Review for Emergency Use Authorization of COVID-19 Prevention Agent 'Evusheld'

Approval Decision Made Through Clinical Data Review and Expert Advisory Meetings

[Image source=AP Yonhap News]

[Asia Economy Reporter Kim Young-won] The Ministry of Food and Drug Safety announced on the 13th that it has begun reviewing the emergency use authorization for 'Evusheld,' an antibody treatment for COVID-19 prevention. This action follows the Korea Disease Control and Prevention Agency's request for emergency use authorization of Evusheld on the 10th.

The Ministry of Food and Drug Safety will review the submitted clinical and quality data, hold expert advisory meetings, and conduct deliberations through the 'Public Health Crisis Response Medical Product Safety Management and Supply Committee' to decide whether to grant emergency use authorization for Evusheld.

Evusheld, developed by AstraZeneca (AZ) in the United Kingdom, is an antibody drug that directly administers antibodies to immunocompromised individuals who have difficulty forming antibodies in their bodies through COVID-19 vaccination, such as patients with hematologic cancers, patients undergoing immunosuppressive therapy after organ transplantation, and those with congenital immunodeficiency. Evusheld binds to the spike protein of the COVID-19 virus, inhibiting the virus from invading human cells.

Countries such as the United States, the United Kingdom, and Singapore are already using Evusheld for pre-exposure prophylaxis. The U.S. Food and Drug Administration (FDA) approved the emergency use of Evusheld in December last year, and Europe recommended marketing authorization in March this year.

The emergency use authorization system allows the use of unapproved drugs domestically when appropriate responses are needed in public health crisis situations. Once the crisis ends, the use of the drug may be suspended or the drug may be recalled or disposed of.

Domestically, the oral COVID-19 treatments Paxlovid and Lagevrio received emergency use authorization in December last year and March this year, respectively.

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