FDA Limits Use of Certain Monoclonal Antibodies to Treat COVID-19 Due to Omicron Variant

The FDA revised the authorization for two monoclonal antibody treatments, bamlanivimab and etesevimab (administered together) and REGEN-COV (casirivimab and imdevimab), to limit their use to only when the patient is likely to have been infected with or exposed to a variant that is susceptible to these treatments.

The FDA states that these two treatments are highly unlikely to be active against the omicron variant, the dominant variant circulating through the country at this time. Thus, these treatments are not authorized for use in any US states, territories, or jurisdictions at this time. This avoids exposing patients to side effects, such as injection site reactions or allergic reactions, which can be potentially serious, from specific treatment agents that are not expected to provide benefit to patients who have been infected with or exposed to the omicron variant. Several other therapies that are expected to work against the omicron variant are authorized or approved to treat patients with mild-to-moderate COVID-19 who are at high risk for progression to severe disease.