The U.S. Food and Drug Administration (FDA) has revoked the Emergency Use Authorizations (EUAs) for four monoclonal antibody (mAb) products formerly used in the treatment of COVID-19. This decision, announced recently, comes after more than a year of these treatments being unauthorized for use due to the emergence and persistence of SARS-CoV-2 variants resistant to these specific mAbs.
Previously, the FDA had limited each EUA, effectively halting the authorization for emergency use of each respective mAb product when it became clear that circulating variants were not susceptible. These limitations were implemented to allow healthcare facilities and providers to maintain inventories of the mAbs in the event that future SARS-CoV-2 variants regained susceptibility. However, the anticipated shift in variant susceptibility did not occur, and the high frequency of non-susceptible variants has persisted.
Furthermore, the shelf life for nearly all lots of these mAb products has now expired, rendering them unusable. Given these factors, the FDA has determined that the EUAs should be formally revoked.
The specific monoclonal antibody products affected by this revocation are those that had previously been authorized for emergency use in treating COVID-19 but have since become ineffective against prevalent variants. The FDA's decision reflects the evolving nature of the SARS-CoV-2 virus and the need for treatments to remain effective against current strains. This action underscores the importance of ongoing surveillance and adaptation in the face of viral evolution during a pandemic.
