FDA halts use of Regeneron, Eli Lilly antibody COVID-19 treatments

Jan. 24 (UPI) -- The U.S. Food and Drug Administration on Monday removed two monoclonal antibody therapies from the list of treatments for COVID-19, saying they are ineffective against the Omicron variant.

The combination of bamlanivimab and estevimab from Eli Lilly and Regeneron's REGEN-COV will be limited to use only when a patient is likely to have been infected with or exposed to "a variant that is susceptible to these treatments," the FDA said in a statement.

"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 United States, these treatments are not authorized for use in any U.S. states, territories and jurisdictions at this time," Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research, said.

According to the U.S. Centers for Disease Control and Prevention, the Omicron variant is responsible for more than 99% of U.S. COVID-19 cases.

This, Cavazzoni said, means 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, meaning the treatments are not authorized to be used at this time."

Cavazzoni added that removing the treatments avoids exposing patients to side effects, such as allergic reactions or reactions at the injection site.

Use of the treatments may be authorized again "if patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to these treatments," the FDA said.

The agency noted that other treatments, including sotrovimab -- another monoclonal antibody -- along with antiviral treatments such as Paxlovid, remdesivir and molnupiravir, which are expected to work against Omicron.