US FDA revokes authorization for four COVID antibody drugs (updated)

Vir Biotechnology

23/12/2024 18:13

(Adds background throughout)
       Dec 23 (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  LLY.N  and
Regeneron  REGN.O . 
    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  AZN.L  Evusheld, GSK's  GSK.L  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)
 ((Bhanvi.Satija@thomsonreuters.com; Outside U.S. +91
9873062788;))