FDA revokes EUAs for four monoclonal antibody products

At the request of the individual product sponsors, the US Food and Drug Administration (FDA) has revoked the Emergency Use Authorizations (EUAs) for four respective monoclonal antibody (MAb) products that had been authorized for emergency use as part of the United States government’s response to the COVID-19 public health emergency.

As of Friday, the EUAs for Eli Lilly’s (NYSE: LLY) bebtelovimab, UK pharma major AstraZeneca’s (LSE: AZN) Evusheld(tixagevimab co-packaged with cilgavimab), Vir Biotechnology (Nasdaq: VIR) sotrovimab, and REGEN-COV(casirivimab and imdevimab), from Regeneron Pharmaceuticals (Nasdaq: REGN),have been revoked.

The four MAb products have not been authorized for administration to patients for more than a year due to the high frequency of circulating SARS-CoV-2 variants that are not susceptible to each particular MAb product. Previously, the FDA, at the appropriate time, based on a limitation in each EUA, announced that the respective MAb product was no longer authorized for emergency use.