FDA proposes new rules for ‘healthy’ label on food packaging


The Food and Drug Administration (FDA) said on Wednesday that the COVID-19 monoclonal antibody treatment bebtelovimab from Eli Lilly is no longer authorized for emergency use in the U.S. as it is not expected to be effective at neutralizing the two most dominant omicron subvariants in the country right now.

The omicron subvariants BQ.1 and BQ.1.1 collectively account for 57.3 percent of COVID-19 cases in the U.S. right now, having pushed the BA.5 omicron subvariant out as the dominant subvariant earlier this month.

“Given that a COVID-19 infection is likely to be caused by a non-susceptible SARS-CoV-2 variant, and consistent with the terms and conditions of the Letter of Authorization, bebtelovimab is not currently authorized for emergency use in any U.S. region at this time,” the FDA said in a statement.

The agency stated that Eli Lilly and its distributors have paused distribution of bebtelovimab until further notice and the Administration for Strategic Preparedness and Response has also paused the fulfillment of any pending requests for the drug.

For the moment, the FDA is recommending that remaining supplies of bebtelovimab be retained in case a variant that is susceptible to the drug becomes more prevalent in the U.S. in the future.

“Lilly and the FDA agree that it is not medically appropriate, at this time, to treat high-risk patients with mild-to-moderate COVID-19 with bebtelovimab in the US,” Eli Lilly said in a statement, confirming that its monoclonal antibody treatment does not appear to neutralize the BQ.1 and BQ.1.1 subvariants.

“Lilly continually monitors the global COVID-19 environment, assessing the neutralization activity of potential antibody therapies against a wide array of existing and emerging mutations and variants,” said the company. “Lilly will continue to search and evaluate monoclonal antibodies to identify potential candidates for clinical development against new variants.”

Monoclonal antibodies function by mimicking natural antibodies produced by the immune system, limiting how much a virus can replicate inside a person’s body. Before vaccines and treatments were available, monoclonal antibodies were one of the only treatments available for COVID-19 infections.

In 2020, former President Trump was given a round of monoclonal antibodies when he was hospitalized with COVID-19, later calling the treatment a “miracle.”

With this treatment no longer being distributed or authorized for use, the FDA advised that health care providers choose “appropriate” treatments including the authorized antivirals Paxlovid, Veklury and Lagevrio.

The agency also recommended the use of convalescent plasma — taken from the blood of people who have recovered from COVID-19 infections — for patients who have compromised immune systems.

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