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FDA May Limit Use of Two COVID Antibody Treatments

HealthDay News
by By Robin Foster HealthDay Reporter
Updated: Jan 24th 2022

new article illustration

MONDAY, Jan. 24, 2022 (healthDay News) -- 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 GlaxoSmithKline's 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% of U.S. cases, a senior official with knowledge of the process told CNN.

But some governors are not heeding that advice. Over 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 criticized the Biden administration for pausing shipments of the monoclonal antibodies, and has pushed for the treatment to remain widely available in his state. During a Jan. 3 media briefing, DeSantis claimed his administration had seen the treatments work on Omicron patients, CNN reported. Nearly 13,000 doses of Regeneron were used in Florida over 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 coronavirus cases in his state, often pushing the treatment more vigorously than vaccines. Last summer, he introduced clinics where individuals could receive the treatment right after symptoms surface or there is exposure to someone with COVID-19.

Other governors have followed suit: Texas Gov. Greg Abbott last year opened "infusion centers" where COVID-positive patients could receive monoclonal antibody treatments. Abbott himself received Regeneron's treatment when he tested positive for coronavirus back in August, when the Delta variant was predominant, 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.

Instead, the Biden administration has pushed for other treatments that have demonstrated greater effectiveness against the Omicron variant, including the Pfizer and Merck antiviral pills, GlaxoSmithKline's antibody treatment and the antiviral remdesivir. On Friday, the FDA expanded the use of remdesivir for treatment of mild to moderate COVID-19 to children and people who aren't hospitalized.

More information

Visit the U.S. Centers for Disease Control and Prevention for more on COVID antibody treatments.