FDA May Limit Use of Two COVID-19 Antibody Treatments

The U.S. Food and Drug Administration may soon curtail the use of two monoclonal antibody treatments that do not appear to work against the highly contagious omicron variant.

The treatments made by Regeneron and Eli Lilly performed well against earlier variants, but only the GlaxoSmithKline antibody therapy has stayed strong against omicron. Last week, the National Institutes of Health updated its guidelines to advise clinics against using these treatments on patients with mild-to-moderate COVID-19 due to their diminished effectiveness.

Meanwhile, senior health officials in the Biden administration have called governors and state health officials to urge them not to use the Regeneron and Lilly antibody cocktails since the omicron variant now accounts for more than 99 percent of U.S. cases, a senior official with knowledge of the process told CNN. But some governors are not heeding that advice. During the last two weeks, states have distributed nearly 110,000 doses of the Lily and Regeneron treatments, according to a federal database maintained by the Department of Health and Human Services, CNN reported.

Earlier this month, Florida governor Ron DeSantis claimed his administration had seen the treatments work on omicron patients, CNN reported. Nearly 13,000 doses of Regeneron were used in Florida during the past two weeks, more than any three other states combined. "Omicron is not the only variant that's out there," DeSantis said. "And it's something that we actually have seen applied with omicron patients and we have seen symptoms resolved."

But Regeneron itself has stated that its monoclonal antibody treatment, known as REGEN-COV, is now ineffective against the omicron variant. Still, DeSantis has made monoclonal antibodies a cornerstone of his response to surges of COVID-19 cases in his state, often pushing the treatment more vigorously than vaccines. Other governors have followed suit: Texas Gov. Greg Abbott last year opened "infusion centers" where COVID-19-positive patients could receive monoclonal antibody treatments, CNN reported.

After the omicron variant was first detected in the United States at the beginning of December, the Biden administration continued to ship the Regeneron and Lily treatments while delta remained a threatening variant. But with omicron dominating now, federal officials had hoped most states would stop using the treatments, a senior official told CNN.