FDA pulls authorization for Covid monoclonal antibodies

The US drugs regulator has rescinded its authorisation for the monoclonal antibody treatments made by Eli Lilly and Regeneron, which proved highly effective at fighting earlier strains of Covid-19 but do not work well against the Omicron variant.

The Food and Drug Administration announced on Monday it was removing its emergency authorisation for doctors to prescribe the treatments, which work by infusing patients with proteins which mimic the body’s immune response.

Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, 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 authorised for use in any US states, territories, and jurisdictions at this time.”

The FDA said it could authorise the treatments again if they are proven to be effective against Covid-19 variants circulating in particular regions.