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FDA Expected to Sharply Restrict Use of Two Monoclonal Antibodies, Spurring a Halt in Federal Shipments of The Drugs

The Food and Drug Administration is poised as soon as Monday (Jan. 24) to restrict two monoclonal antibodies, saying the covid-19 treatments should not be employed in any states because they are ineffective against the dominant omicron variant, according to two senior administration health officials.

As a result, the Biden administration will pause distribution of the therapies, manufactured by Regeneron Pharmaceuticals and Eli Lilly, to the states.

“We want to make sure that patients get treatments that are effective, not treatments that don’t work,” said one of the officials, who spoke on the condition of anonymity to describe internal discussions.

Biden administration officials noted that several therapies remain effective against omicron, including sotrovimab — a monoclonal antibody made by GlaxoSmithKline and Vir Biotechnology — and antiviral pills by Pfizer and by Merck and its partner, Ridgeback Biotherapeutics.

Senior Biden administration officials last week called health officials in several states to urge them to stop using the Regeneron and Lilly drugs.

An official who spoke on the condition of anonymity expressed frustration that some governors are still promoting ineffective medications.

“Frankly, at this stage, it’s dangerous that they would do that. It’s beyond irresponsible to use these products that aren’t without their own risks when we know they offer basically zero benefit,” he said.

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