The FDA is withdrawing the antibody bebtelovimab as a result of it isn’t efficient towards Omicron BQ.1
An Eli Lilly and Company pharmaceutical manufacturing facility is pictured at 50 ImClone Drive on March 50, 2021 in Branchburg, New Jersey.
Fresh Mike | Reuters
An important monoclonal antibody used to treat immunocompromised people who contract Covid is no longer approved for use in the US because it is not effective against emerging omicron subvariants.
The FDA said in a statement Wednesday that bebtelovimab is not approved for use because it is not expected to neutralize subvariants Omicron BQ.1 and BQ.1.1. They cause 57% of new infections nationwide and account for the majority of cases in all but one US region.
The Department of Health and Human Services is holding back pending requests for bebtelovimab, and manufacturer Eli Lilliy has halted commercial distribution of the antibody treatment until further notice, according to the FDA notice.
But bebtelovimab stocks should be kept on hand in case Covid variants that the antibody can neutralize become dominant again in the future, according to the FDA.
Bebtelovimab is a single-dose injection given to people who contract Covid and are at high risk of developing serious disease but cannot take other FDA-approved treatments, such as the oral antiviral Paxlovid. Many people with weakened immune systems, such as B. Organ transplant patients cannot take Paxlovid together with other medicines that they need.
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US health officials have warned that immunocompromised people are at increased risk from Covid this winter as immune-evading omicron subvariants threaten to knock out antibody treatments they rely on to keep themselves safe from Covid protection.
dr Ashish Jha, the White House Covid coordinator, said in October that Congress’ failure to pass additional Covid funds means treatments will dwindle as new variants render them ineffective.
“We had hoped that over time as the pandemic progressed and as we progressed in our fight against this virus, we would expand our medicine cabinet,” Jha told reporters. “Due to a lack of congressional funding, this medicine cabinet has actually shrunk and that is putting vulnerable people at risk.”
President Joe Biden has urged people with compromised immune systems to consult with their doctors about what extra precautions they should take this winter to stay safe.