The U.S. Drug Enforcement Administration is withdrawing approval for Covid’s monoclonal antibodies


The US drug regulator has revoked its authorization to treat with monoclonal antibodies made by Eli Lilly and Regeneron, which have been shown to be very effective in combating earlier strains of Covid-19, but are not working well against the Omicron variant.

The Food and Drug Administration announced on Monday that it was removing its urgent permission for doctors to prescribe treatments that work by infusing patients with proteins that mimic the body’s immune response.

Patricia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement: treatment is not currently permitted in any U.S. state, territory, or jurisdiction. ”

The FDA said it could re-authorize the treatment if it was shown to be effective against Covid-19 variants circulating in certain regions.

Regeneron’s treatment helped then-President Donald Trump recover quickly from the virus when he was infected in 2020. But federal agencies are discouraging their use as Omicron has become the dominant strain in the United States, saying it has not it is worth exposing patients to potential side effects.

This sparked controversy with Ron DeSantis, the Republican governor of Florida, who accused the Joe Biden administration of “playing games” with therapies by limiting their supply.

According to studies, critics of the governor recently questioned the practice of continuing to provide treatments for Covid-19, which have lost their effectiveness against the Omicron variant, according to studies.

Christian Ramers, an infectious disease specialist at San Diego Family Health Centers who previously offered monoclonal antibodies to Eli Lilly and Regeneron, said it was unethical to continue providing them.

“It’s really unfortunate that this is happening in some places,” Ramers said. “It was quite clear that Regeneron and Eli Lilly had almost no activity, even at very high concentrations against Omicron. This was realized quite early by some. . . studies. “

Health experts said the declining effectiveness of the two most commonly used antibody treatments led to a shortage of a third treatment with the monoclonal antibody sotrovimab, which is manufactured by GlaxoSmithKline and Vir Biotechnology and has shown activity against Omicron.

However, new antiviral drugs developed by Pfizer and Merck began to be made available by health clinics after their recent approval by the FDA.

Eli Lilly said she agreed with the FDA that it was not currently medically appropriate to treat patients with mild to moderate Covid-19 with its monoclonal antibody, as it was not effective in treating Omicron.

“The status of the permit will change as necessary, depending on the prevalence and trends of the options for concern,” it said.

Eli Lilly said she was working urgently with the FDA to prove that a variety of antibody therapies were effective against all anxiety disorders, including Omicron.

Regeneron did not immediately respond to a request for comment.



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