FDA Limits Use of Two Monoclonal Antibodies For COVID-19 Treatment Due to the Omicron Variant

The United States Food and Drug Administration (FDA) released a statement today, according to which it limits the use of certain monoclonal antibodies to treat COVID-19 due to the Omicron variant.

According to the statement, FDA revised the authorizations for two monoclonal antibody treatments – bamlanivimab and etesevimab from Eli Lilly and Company (NYSE: LLY) and REGEN-COV (casirivimab and imdevimab) from Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN), as the most recent data show these treatments are highly unlikely to be active against the Omicron variant, which is estimated to account for more than 99% of cases in the United States as of Jan. 15.

Given that it is highly unlikely that COVID-19 patients seeking care in the U.S. at this time are infected with a variant other than Omicron, FDA doesn’t authorize these treatments for use in any U.S. 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 the use of these treatments may be authorized in these regions.

Several other therapies, such as Paxlovid from Pfizer Inc. (NYSE: PFE), sotrovimab from GlaxoSmithKline plc (LSE/NYSE: GSK) and Vir Biotechnology, Inc. (Nasdaq: VIR), Veklury (remdesivir) from Gilead Sciences, Inc. (NASDAQ: GILD), and molnupiravir from Merck & Co., Inc. (NYSE: MRK), are expected to work against the Omicron variant and are authorized or approved by FDA to treat patients with mild-to-moderate COVID-19 who are at high risk for progression to severe disease, including hospitalization or death.

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