U.S. FDA to restrict use of Regeneron, Lilly COVID antibody drugs – WaPo

The FDA changed the emergency use authorizations for Regeneron and Eli Lilly’s COVID-19 antibody therapies on Monday, limiting their use because the medications are unlikely to function against the Omicron variant.

The FDA will revise the monoclonal antibody emergency use authorizations, according to the Washington Post, citing two senior administration health officials.

The FDA also stated that if the medicines work against possible new variations, they may be approved for use in certain places.

The agency did highlight other treatments that are expected to be effective against Omicron, according to Reuters, including a rival antibody drug from GlaxoSmithKline, and Vir Biotechnology as well as recently authorized antiviral pills from Pfizer, and Merck & Co.

This means the drugs— Regeneron Pharmaceuticals Inc.’s REGEN-COV and Eli Lilly & Co.’s bamlanivimab and etesevimab—shouldn’t be used in any U.S. states, territories, or jurisdictions at this time, the Food and Drug Administration said Monday.

After the FDA move, the Department of Health and Human Services (HHS) said it wasn’t going to include the antibody drugs in the latest Covid-19 drug shipment to states.

This move is going to make it difficult for states, like Florida, that have been taking steps to provide the drugs to people newly infected with Covid-19 to keep doing so.

“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.

The highly contagious Omichron variant was estimated to account for more than 99 percent of cases in the United States as of Jan. 15. Click Orlando.com. is reporting 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, 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.

“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, Joseph A. Ladapo criticized the government publicly on Twitter.