FDA Revokes EUAs for Two Monoclonal Antibodies Shown to be Ineffective Against Omicron

January 26, 2022

The FDA has revoked the Emergency Use Authorization (EUA) for Regeneron’s REGEN-COV (casirivimab plus imdevimab) and Eli Lilly’s (bamlanivimab and etesevimab), both monoclonal antibodies that both companies said were shown to be less effective in targeting Omicron.

Omicron now accounts for most COVID-19 infections in the U.S.

If the infused drugs prove effective against future variants, the FDA says it can reauthorize their use.

Monoclonal antibodies that remain available and have shown efficacy against Omicron are Gilead Sciences’ Veklury (remdesivir) and GlaxoSmithKline’s and Vir Biotechnology’s Xevudy (sotrovimab).

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