FDA Scales Back Use of 2 Monoclonal Antibody Treatments for COVID-19

After months of reports that two monoclonal antibody treatments for COVID-19 were not effective against the Omicron COVID-19 variant, the Food and Drug Administration (FDA) is halting their use in the United States.

On January 24, the FDA amended the emergency use authorizations (EUAs) for bamlanivimab and etesevimab (administered together) and REGEN-COV (casirivimab and imdevimab), limiting their use to only when the patient has been exposed to or infected with a COVID variant known to be treatable with these drugs. The drugs are manufactured by Eli Lilly and Regeneron, respectively.

“In light of the most recent information and data available…the FDA revised the authorizations to limit their use to only when the patient is likely to have been infected with or exposed to a variant that is susceptible to these treatments,” said Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research in a statement.

However, it is highly unlikely that anybody in the U.S. would be exposed to a variant other than Omicron at this time. Therefore, the treatments aren’t to be used at all.

“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,” Cavazzoni said.

The Department of Health and Human Services, which pays for and distributes the treatments, recently stopped shipping them to states, according to reporting by the Washington Post.

A Long Time Coming

The decision, and the time it took the FDA to change the EUAs, underscores the difficulty that the U.S. can face when treating variants of the coronavirus, Gregory Poland, MD, an infectious disease specialist at the Mayo Clinic, told Verywell.

Some U.S. health systems, including several New York City hospitals, had already stopped using the two treatments at the end of 2021. Early research published in December suggested they would be ineffective against Omicron.

How Can You Know Which Variant You're Infected With?

While the FDA’s language suggests that people with an earlier COVID-19 variant, like Delta, could use these monoclonal antibody treatments, there’s really no way to know which variant you’re infected with, especially at the start of a new wave.

“We’re operating on a guess. We don’t have a point of care test to tell us what [variant] we’re treating,” Poland said.

While laboratory-based genomic sequencing tests can determine COVID-19 variants, those results are not consumer-facing. They’re only used for public health surveillance purposes. In fact, the Centers for Medicare and Medicaid Service (CMS) says labs cannot return sequencing test results to patients or providers if the lab is not certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, which many are not.

Which Drugs Can Still Be Used to Treat COVID-19?

According to the National Institutes of Health’s COVID-19 Treatment Guidelines Panel, the following treatments can be prescribed for patients with mild-to-moderate COVID-19 who are at risk of developing a severe case of the virus, including hospitalization or death:

• Paxlovid: An antiviral pill made by Pfizer. Authorized for use in people aged 12 and older
• Molnupiravir: An antiviral pill made by Merck. Authorized for use in people aged 18 and older
• Veklury (remdesivir): An antiviral IV infusion made my Gilead Sciences. Approved for use in people aged 12 and older

The information in this article is current as of the date listed, which means newer information may be available when you read this. For the most recent updates on COVID-19, visit our coronavirus news page.