Healthcare

Biden administration limits use of two monoclonal antibody treatments

The Food and Drug Administration (FDA) on Monday significantly restricted the use of a pair of monoclonal antibody treatments for COVID-19 because they are ineffective against the omicron variant.

The agency said the therapies made by Eli Lilly and Regeneron should only be used in patients that have been infected with or exposed to a variant that is susceptible to the treatments.  

“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,” the FDA said. 

However, the agency did not revoke the emergency authorization.

“In the future, if patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to these treatments, then use of these treatments may be authorized in these regions,” the FDA said.

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. 

As a result, FDA noted that “it’s highly unlikely that COVID-19 patients seeking care in the U.S. at this time are infected with a variant other than omicron.”

Still, the treatments have remained popular with some governors despite their ineffectiveness. Earlier this month, Florida Gov. Ron DeSantis (R) criticized the Biden administration for pausing shipments of the treatments in December, and pushed for the state to be able to secure its own supply.

The administration resumed shipments after the criticism, while omicron was spreading but delta was still the primary variant in the country.

Florida Surgeon General Joseph Ladapo and DeSantis have contended the delta variant still exists in the state, and have said they disagree that the antibody treatments are not effective against omicron.

For the week ending Jan. 23, states received nearly 100,000 combined doses of Regeneron’s treatment and Eli Lilly’s treatment, according to the Department of Health and Human Services. 

A senior administration official said further shipments would be paused in light of FDA’s actions. 

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 emphasized that while the treatments are critical for patients with mild to moderate COVID-19 who are at high risk for progression to severe disease, they are not a substitute for vaccination.

Healthcare