FDA limits use of certain MAbs to treat COVID-19

As we have throughout the COVID-19 pandemic, the US Food and Drug Administration has used the best available science as the virus has evolved to make informed decisions with the health and safety of the American public in mind. Ensuring that healthcare providers on the frontlines have the best tools available to treat patients is a top priority for the agency, according to a statement from Dr Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research.

In light of the most recent information and data available, the FDA revised the authorizations for two monoclonal antibody (MAb) treatments – Eli Lilly’s (NYSE: LLY) bamlanivimab and etesevimab (administered together) and Regeneron’s (Nasdaq: REGN) 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.

Because data show these treatments are highly unlikely to be active against the omicron variant, which is circulating at a very high frequency throughout the USA, these treatments are not authorized for use in any US states, territories, and jurisdictions at this time. In the future, if patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to these treatments, then use of these treatments may be authorized in these regions.