FDA pauses US authorization for Eli Lilly's COVID treatment drug
FDA said COVID drug bebtelovimab was not expected to neutralize omicron subvariants BQ.1, BQ.11
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The Food and Drug Administration announced on Wednesday that Eli Lilly's COVID-19 drug bebtelovimab is not currently authorized for emergency use in the U.S.
The agency said that bebtelovimab was not expected to neutralize omicron subvariants BQ.1 and BQ.1.1., citing data included in the Health Care Provider Fact Sheet.
"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 release.
According to the Centers for Disease Control and Prevention, the combined proportion of cases caused by the subvariants is above 57% nationwide, with figures showing a "sustained trend of increasing prevalence across all regions."
"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 U.S.," Lilly told FOX Business in a statement. "Based on pseudovirus data, Lilly can confirm that bebtelovimab does not retain neutralization activity against the BQ.1 and BQ.1.1 variants, most likely due to an amino acid K444T substitution."
"Lilly will continue to search and evaluate monoclonal antibodies to identify potential candidates for clinical development against new variants," it added.
Eli Lilly and Company headquarters in Madrid. (Photo by Cristina Arias/Cover/Getty Images / Getty Images)
It said that Eli Lilly and its authorized distributors have paused commercial distribution of bebtelovimab until further notice.
In addition, the Administration for Strategic Preparedness and Response has paused the fulfillment of any pending requests under its Bebtelovimab Product Replacement Initiative.
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AstraZeneca Plc's monoclonal antibody Evusheld is also authorized for protection against COVID-19 infection in some people.
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The FDA said it would continue to work with agencies on surveillance of variants that might impact the use of therapies authorized for emergency use and will consider additional action as new information is made available.
The drug received an authorization from the FDA in February in adults and pediatric patients who are at high risk for progression to severe COVID-19 and for whom alternative treatment options approved by the FDA are not accessible or clinically appropriate.
In an October letter, the FDA concluded that the emergency use of bebtelovimab for treatment of mild-to-moderate COVID-19 in certain adults and pediatric patients who are at high risk for progression to severe disease "may be effective" and "meets the criteria for issuance of authorization."
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Reuters contributed to this report.