FDA Revokes Authorization Of Antibody Drugs That Don’t Work Against Omicron

The U.S. Food and Drug Administration has revoked the emergency use authorization for two COVID antibody treatments because they do not work against the Omicron variant. The decision comes a few weeks after the government stopped distributing antibody drugs made by Regeneron and Eli Lilly.

Antibody drugs developed by GlaxoSmithKline do work against the Omicron variant and are still authorized for use by the FDA.

“It’s highly unlikely that COVID-19 patients seeking care in the U.S. at this time are infected with a variant other than Omicron, and these treatments are not authorized to be used at this time,” the FDA said.

The Omicron variant makes up nearly all cases of COVID-19 in the United States.

Both companies said they are working to adapt their treatments to fight the Omicron variant.

“Lilly and the FDA agree that it is not medically appropriate, at this time, to treat patients with mild to moderate Covid-19 with bamlanivimab and etesevimab together in the U.S.,” a Lilly spokeswoman said.

Regeneron said that it hopes to begin clinical trials in the coming months.

The FDA did not rule out reauthorizing the treatments if they are effective against other variants that may evolve in the future.

Florida Governor Ron DeSantis blasted the decision by the FDA.

“Early this morning, thousands of Floridians woke up to news that their appointments to get treatment for COVID-19 infection were canceled by the administration, which revoked, outright revoked authorization for two very popular monoclonal antibody treatments at the state of Florida really pioneered over the summer,” DeSantis said, according to the Orlando Sentinal.

He claimed that the decision was based on “a single, non-peer-reviewed, non-clinical study that was actually done by a consultant for a rival company to the other two monoclonal antibody treatments.”

“It’s really a reckless decision to be able to take this option away from patients,” he added.

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