Jan 24, 2022 - Health

FDA limits use of Regeneron and Lilly COVID antibody treatments

Rebecca Falconer

A coldbox containing monoclonal antibody treatments at a Regeneron clinic in Pembroke Pines, Florida, U.S., on Wednesday, Aug. 18. — A coldbox containing monoclonal antibody treatments at a Regeneron clinic in Pembroke Pines, Fla., in August. Photo: Eva Marie Uzcategui/Bloomberg via Getty Images

The FDA said Monday it's limiting the use of two monoclonal antibody therapies as COVID-19 treatments because data indicates they're "highly unlikely" to be effective against the dominant Omicron variant.

Driving the news: The FDA revised the authorizations for Regeneron and Eli Lilly "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," per a statement from the agency.

The FDA pointed to CDC statistics showing that Omicron accounted for 99% of cases in the U.S. as of Jan. 15 and noted that "data show these treatments are highly unlikely to be active" against Omicron.
The action "avoids exposing patients to side effects, such as injection site reactions or allergic reactions, which can be potentially serious, from specific treatment agents that are not expected to provide benefit to patients who have been infected with or exposed to" Omicron, the FDA added.

The latest: All Florida monoclonal antibody sites were closed until further notice following the FDA's decision, per a statement from the state's health department.

The big picture: Both Eli Lilly's and Regeneron's treatments were found to be effective in preventing COVID-19 hospitalizations before Omicron's arrival, the New York Times notes.

The U.S. government had paused distribution of these drugs in December due to concerns about their effectiveness against Omicron.

It restarted distribution after complaints from some Republican governors, including Florida's Ron DeSantis — who in an emailed statement on Monday night called the FDA's decision "reckless."

What they're saying: Regeneron said in a statement that pending regulatory discussions, "new therapeutic candidates could enter the clinic in coming months," per Reuters.

Lilly noted in its December report that its antibody candidate, bebtelovimab, was found to neutralize variants including Omicron, Reuters notes

Editor's note: This article has been updated with details of the Florida monoclonal antibody sites closure.

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FDA limits use of Regeneron and Lilly COVID antibody treatments

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