FDA halts use of Regeneron, Eli Lilly antibody drugs deemed ineffective agianst Omicron thumbnail

FDA halts use of Regeneron, Eli Lilly antibody drugs deemed ineffective agianst Omicron

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.

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