An Eli Lilly and Company pharmaceutical manufacturing plant is pictured at 50 ImClone Drive in Branchburg, Recent Jersey, March 5, 2021.
Mike Segar | Reuters
A key monoclonal antibody used to treat individuals with weak immune systems who catch Covid is not any longer authorized to be used within the U.S. since it will not be effective against emerging omicron subvariants.
The FDA, in a notice Wednesday, said bebtelovimab will not be approved to be used since it will not be expected to neutralize the omicron BQ.1 and BQ.1.1 subvariants. They’re causing 57% of recent infections nationally and make up a majority of cases in every U.S. region except one.
related investing news
The Health and Human Services Department is putting on hold pending requests for bebtelovimab, and the manufacturer Eli Lilliy has also halted business distribution of the antibody treatment until further notice, in line with the FDA notice.
But bebtelovimab stocks must be kept available within the event that Covid variants which the antibody can neutralize change into dominant again in the longer term, in line with FDA.
Bebtelovimab is a single-dose injection administered to individuals who catch Covid and are at high risk of developing severe disease, but cannot take some other FDA-approved treatments resembling the oral antiviral Paxlovid. Many individuals with weak immune systems, resembling organ transplant patients, cannot take Paxlovid with other medications they need.
U.S. health officials have warned that individuals with weak immune systems face a heightened risk from Covid this winter, because more immune evasive omicron subvariants threaten to knock out antibody treatments they depend on to remain protected from Covid.
Dr. Ashish Jha, the White House Covid coordinator, said in October that the failure of Congress to pass additional Covid funding means treatments will dwindle as latest variants render them ineffective.
“We had hoped that over time because the pandemic went along, as our fight against this virus went along, we can be expanding our medication cabinet,” Jha told reporters. “Due to lack of congressional funding that medicine cabinet has actually shrunk and that does put vulnerable people in danger.”
President Joe Biden has called on individuals with weak immune systems to seek the advice of with their physicians about what extra precautions they need to take this winter to remain protected.
