The U.S. health regulator on Monday revised the emergency use authorizations for COVID-19 antibody treatments from Regeneron and Eli Lilly to limit their use, as the drugs are unlikely to work against the Omicron variant.
The FDA action will involve revising the emergency use authorizations for the monoclonal antibodies, the Washington Post said, citing two senior administration health officials.
The FDA also said that the treatments may be authorized for use in certain regions if they work against potential new variants.
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.
Florida Health Department fights back
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.