Last Remaining Monoclonal Treatment for COVID-19 Revoked by FDA 

December 14, 2022

Research shows that monoclonal antibody treatments are ineffective against the omicron subvariants that currently account for most COVID-19 cases. As a result, the Food and Drug Administration (FDA) recently reversed its authorization of bebtelovimab, the last remaining monoclonal antibody treatment available for COVID-19. Bebtelovimab was previously given to patients who were at a higher risk of severe disease.  

Monoclonal antibody treatments use antibodies to stimulate a recipient’s immune system. The FDA has authorized six monoclonal antibody treatments over the past two years, all of which have been rendered less effective by and eventually revoked because of the prevalence of omicron subvariants.  

Omicron subvariants BQ.1 and BQ.1.1. account for about 62% of recent COVID-19 cases, and according to the FDA, are not being neutralized by bebtelovimab. The current recommendation for people at high risk for severe COVID-19 is Paxlovid, a series of pills that have remained effective against new variants. 

Monoclonal antibody treatments are still typically recommended for people taking certain immunosuppressive medications since Paxlovid can interact negatively with several of those drugs. Other options for immunocompromised people who are unable to take Paxlovid include the antiviral drug remdesivir or convalescent plasma, which is the donated blood from people who have recovered from COVID-19.  

Learn more about the new omicron variants and monoclonal antibody treatment here.