FDA says to not use Regeneron; state-run monoclonal sites closed in Florida

ORLANDO, Fla. – The Food and Drug Administration on Monday revised its authorizations for two monoclonal antibody treatments because they are “highly unlikely to be active against the omicron variant” of COVID-19.

CDR Maguire, the contractor for monoclonal treatments in Florida, said all appointments at state-run monoclonal sites have been canceled.

The FDA announced the decision to revise the authorizations for REGEN-COV, commonly called Regeneron after the company that makes it, and bamlanivimab and etesevimab (a treatment taken together) for patients who have the omicron variant of COVID-19.

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The authorizations now specifically limit the treatments’ usage to patients likely to have been infected by or exposed to a different COVID variant. However, the FDA says it’s estimated that more than 99% of COVID-19 cases accounted for in the U.S. are linked to the omicron variant.

The U.S. does not have a testing protocol that tells patients immediately if they have a specific variant of COVID-19. A sampling at certain wastewater treatment plants in Central Florida over the last week or so has found almost no trace of COVID-19 variants other than omicron.

The decision is based on growing research showing the use of those two treatments are not as effective against the omicron variant, and limiting their use avoids exposing patients to side effects. Regeneron itself noted last month that REGEN-COV had “diminished potency against omicron.”

Monoclonal antibody treatments work by mimicking the body’s immune system and its ability to fight off infections like viruses. The treatments were shown to be effective in patients who were sick, but not sick enough to be hospitalized.

While these two treatments are no longer authorized for use, the FDA says sotrovimab, another monoclonal antibody treatment, is still available. There are other authorized treatments available as well, including Paxlovid, remdesivir and molnupiravir.

Florida officials have trumpeted the effectiveness of monoclonal antibody treatments and recently opened several sites in the state. They use Regeneron and bamlanivimab and etesevimab.

In a letter to U.S. Dept. of Health and Human Services, Kenneth Scheppke, the Florida’s Dept. of Health’s deputy secretary, criticized the agency for not notifying states before the announcement by the FDA, especially since the state was trying to meet with HHS on getting more doses of monoclonal antibody treatments. They accused HHS of delaying that meeting because officials knew the announcement was coming.

“To be clear, Florida disagrees with the decision to halt Regen-COV [Regeneron] in the absence of clinically-based evidence, which to date has not been provided by the FDA,” Scheppke said in the letter. “Such decisions from the federal level continue to be (sic) made in this haphazard manner.”

Florida’s surgeon general criticized the government publicly on Twitter.

It is always best to consult your doctor to figure out if you need treatment.