FDA Pulls Authorization for Two Monoclonal Antibody Treatments

The FDA on Monday effectively revoked the emergency use authorization (EUA) for two monoclonal antibody treatments for COVID-19, bamlanivimab and etesevimab (administered together) and REGEN-COV (casirivimab and imdevimab) by limiting their use only to patients likely to have been infected with or exposed to a variant that these therapies are effective at treating. Because of the products’ reduced effectiveness against the omicron variant of the virus, which is circulating at very high frequency in the U.S., the FDA stated that these treatments are not authorized for use in any U.S. states, territories, and jurisdictions at this time. The monoclonal antibody treatment molnupiravir still has an EUA for treatment of mild to moderate COVID-19 in adults who are at high risk for progressing to severe COVID-19. Curi’s informed consent form for molnupiravir is available here.

On January 24, 2022 The Food and Drug Administration (FDA) reported that due to the high frequency of the Omicron variant, the monoclonal treatments, bamlanivimab and etesevimab and REGEN-COV are not currently authorized in any U.S. region. Therefore, these drugs may not be administered for treatment or post-exposure prevention of COVID-19 under the Emergency Use Authorization (EUA) until further notice by the Agency.

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