(Reuters) -The U.S. Food and Drug Administration has revoked the emergency use authorization for four COVID-19 antibody-based drugs, including those from Eli Lilly and Regeneron. 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, […]
U.S.
US FDA revokes authorization for four COVID antibody drugs
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(Reuters) -The U.S. Food and Drug Administration has revoked the emergency use authorization for four COVID-19 antibody-based drugs, including those from Eli Lilly and Regeneron.
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, the FDA said in letters dated earlier this month and posted on its website on Monday.
The FDA revoked the authorization for Lilly’s bebtelovimab, AstraZeneca’s Evusheld, GSK’s sotrovimab and Regeneron’s REGEN-COV.
The companies also do not intend to offer the products in the U.S. anymore, according to the FDA.
The FDA said the companies would notify customers and providers about the revocation with instructions for product destruction or return.
(Reporting by Bhanvi Satija and Sriparna Roy in Bengaluru; Editing by Krishna Chandra Eluri and Vijay Kishore)