Regeneron continues to progress next generation antibodies that retain potency against Omicron, Delta and other variants of concern

The U.S. Food and Drug Administration (FDA) today amended the Emergency Use Authorization (EUA) for Regeneron’s REGEN-COV® (casirivimab and imdevimab) to exclude its use in geographic regions where, based on available information including variant susceptibility and regional variant frequency, infection or exposure is likely due to a variant such as Omicron (B.1.1.529) that is not susceptible to the treatment. With this EUA revision, REGEN-COV is not currently authorized for use in any U.S. states, territories or jurisdictions, since Omicron is currently the dominant variant across the United States. REGEN-COV remains an investigational drug and is not approved for any indication.

The FDA stated that if, in the future, patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to REGEN-COV, then the limitation on use may be revised in these areas.

Regeneron continues to progress next generation antibodies that are active against Omicron, Delta (B.1.617.2) and other variants of concern. The company is working urgently and collaboratively with the FDA to determine how to bring additional safe and effective monoclonal antibody treatments to patients as quickly as possible. Pending regulatory discussions, new therapeutic candidates could enter the clinic in coming months.