WASHINGTON — U.S. regulators restricted the use of a pair of COVID-19 monoclonal antibody therapies after scientific evidence suggested they are unlikely to be effective against the omicron variant.
The Food and Drug Administration said in a statement on Monday that it had decided to limit access to the treatments, which are made by Eli Lilly & Co. and Regeneron Pharmaceuticals Inc., amid the recent surge in omicron infections. The variant, which was first detected last year in southern Africa, now accounts for nearly all new cases of COVID-19 in the U.S.
“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,” said Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research.
