US FDA revokes authorization for four COVID antibody drugs

investing.com 23/12/2024 - 17:25 PM

FDA Revokes Emergency Use Authorization for COVID-19 Antibody Drugs

(Reuters) – The U.S. Food and Drug Administration (FDA) has revoked the emergency use authorization for four COVID-19 antibody-based drugs, including those from Eli Lilly (NYSE:LLY) and Regeneron (NASDAQ:REGN).

The shelf life of the drugs had expired, and they had not been authorized for administration to patients for more than a year due to the circulation of non-susceptible variants. This information was detailed in letters dated earlier this month and posted on the FDA's website on Monday.

The FDA has revoked the authorization for:
– Lilly's bebtelovimab
– AstraZeneca (NASDAQ:AZN)'s Evusheld
– GSK's sotrovimab
– Regeneron's REGEN-COV

The companies have also indicated that they do not intend to offer these products in the U.S. any longer, according to the FDA.

The FDA stated that the companies will notify customers and healthcare providers regarding the revocation, along with instructions for product destruction or return.




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