FDA expected to restrict use of two COVID-19 monoclonal antibody treatments

The Food and Drug Administration is expected to significantly restrict the use of a pair of monoclonal antibody treatments for COVID-19 because they are ineffective against the omicron variant, a senior administration health official confirmed.

As a result, the official said the Biden administration will be pausing the distribution of the therapies made by Eli Lilly and Regeneron to the states.

The action was first reported by The Washington Post.

“We just want to make sure that Americans who get sick are given treatments that work,” the official said. 

The FDA is expected to revise the authorization for the Eli Lilly and Regeneron therapeutics to say they are not authorized for use in the U.S. at this time. The agency is not expected to revoke the authorization in case the drugs are needed again in the future. 

The action from the FDA and the White House follows guidance on Friday from the National Institutes of Health, which recommended against the use of both therapies, saying they are “predicted to have markedly reduced activities” against the omicron variant.

The omicron variant began spreading across the U.S. in late November, and now accounts for more than 99 percent of infections, according to the Centers for Disease Control and Prevention. 

The antibody treatment now most recommended is sotrovimab, from GlaxoSmithKline and Vir Biotechnology. The administration will also continue to allocate doses of Pfizer’s antiviral drug Paxlovid, as well as one made by Merck called molnupiravir. However, both Paxlovid and sotrovimab are in short supply.

The FDA on Friday also expanded the authorization of remdesivir so it can be used in outpatient settings.