FDA Revokes EUA for REGEN-COV (casirivimab and imdevimab) for the Treatment of COVID-19

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December 13, 2024 -- On November 25, 2024, Regeneron requested that the U.S. Food and Drug Administration revoke the Emergency Use Authorization for REGEN-COV (Casirivimab and Imdevimab) since all lots of REGEN-COV manufactured and labeled for use under EUA 091 have expired and Regeneron does not intend to offer this product in the United States anymore. At the time of Regeneron’s request, REGEN-COV was not authorized for use in any region of the United States due to regional variant frequency and the high frequency of circulating SARS-CoV-2 variants that are non-susceptible to REGEN-COV. FDA has determined that it is appropriate to protect the public health or safety to revoke this authorization.

Posted : 2024-12-17 06:00

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