FDA pulls antibody bebtelovimab because not effective against omicron BQ.1

An Eli Lilly and Company pharmaceutical factory is pictured at 50 ImClone Drive in Branchburg, New Jersey, March 5, 2021.

Mike Segar | Reuters

An important monoclonal antibody used to treat people with weakened immune systems with Covid is no longer authorized for use in the United States because it is ineffective against emerging omicron variants.

FDA, in a Wednesday announcement, indicates that bebtelovimab is not approved for use because it is not expected to disable the omicron sub-variants BQ.1 and BQ.1.1. They are causing 57% of new infections nationwide and account for the majority of cases in every region of the US, except one.

Per the FDA announcement, the Department of Health and Human Services is suspending pending requests for bebtelovimab, and manufacturer Eli Lilliy has also halted commercial distribution of the antibody treatment until when there are new announcements.

But stocks of bebtelovimab should be stocked in the event that Covid variants that antibodies can neutralize come back dominate in the future, according to the FDA.

Bebtelovimab is a single-dose injection for people who have Covid and are at high risk for severe illness, but cannot take any other FDA-approved treatment, such as the oral antiviral Paxlovid. Many people with weakened immune systems, such as organ transplant patients, cannot take Paxlovid with other medicines they need.

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US health officials have warned that people with weakened immune systems face a higher risk of contracting Covid this winter, because more immune-evading omicron sub-variants threaten elimination. the antibody treatments they rely on to stay safe from Covid.

Dr Ashish Jha, the White House Covid coordinator, said in October that Congress’ failure to pass additional funding for Covid means that treatments will be dwindling as new variants make them available. inefficient.

“We were hoping that over time as the pandemic passes, as the fight against this virus progresses, we will expand our medicine cabinet,” Jha told reporters. “Because of the lack of congressional funding, the medicine cabinet has really shrunk and that puts vulnerable people at risk.”

President Joe Biden has urged people with weakened immune systems to consult their doctors about what extra precautions they should take this winter to stay safe.


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