FDA Revokes EUAs for Four Monoclonal Antibody Products

December 13, 2024 -- At the request of the individual product sponsors, 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 today, the EUAs for bebtelovimab, Evusheld (tixagevimab co-packaged with cilgavimab), sotrovimab, and REGEN-COV (casirivimab and imdevimab) have been revoked.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, 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. The limitation allowed each EUA to remain in place, and in turn, permitted health care facilities and providers to retain inventory of the particular mAb product in case the susceptibility of future SARS-CoV-2 variants changed. However, the high frequency of circulating SARS-CoV-2 variants that are non-susceptible to these particular mAb products has persisted. In addition, the shelf life for nearly all lots of these products has expired.

The sponsor for each of these revoked EUAs will provide health care facilities and providers with instructions for return and disposal of each respective product.

Source: FDA