The U.S. Food and Drug Administration (FDA) has revoked the Emergency Use Authorizations (EUAs) for two COVID-19 antibody treatments: Evusheld (tixagevimab co-packaged with cilgavimab) and REGEN-COV (casirivimab and imdevimab). These decisions, made in December 2024, reflect the reduced efficacy of these treatments against currently circulating SARS-CoV-2 variants.
Evusheld EUA Revocation
On November 21, 2024, AstraZeneca requested the FDA to revoke the EUA for Evusheld. This request was based on two primary factors: the expiration of all Evusheld lots distributed under EUA 104 and the prevalence of non-susceptible variants exceeding 90% nationally. "At the time of AstraZeneca’s request, Evusheld was not authorized for use in any region of the United States," the FDA noted. The agency determined that revoking the authorization was necessary to protect public health.
REGEN-COV EUA Revocation
Similarly, Regeneron requested the FDA to revoke the EUA for REGEN-COV on November 25, 2024. This decision stemmed from the expiration of all REGEN-COV lots manufactured and labeled under EUA 091, coupled with Regeneron's decision to discontinue offering the product in the United States. The FDA also highlighted that REGEN-COV was not authorized for use in any U.S. region due to the high frequency of circulating SARS-CoV-2 variants resistant to the treatment.
The FDA's decision to revoke these EUAs underscores the challenges of maintaining effective treatments against a rapidly evolving virus. The emergence of new variants necessitates continuous monitoring and adaptation of therapeutic strategies to ensure optimal patient outcomes. The agency has determined that it is appropriate to protect the public health or safety to revoke this authorization.
