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Bebtelovimab

Important Information About Bebtelovimab

On November 30, 2022, the FDA announced that bebtelovimab is no longer authorized for emergency use in the United States because bebtelovimab is not expected to neutralize the Omicron subvariants BQ.1 and BQ.1.1. Eli Lilly and its authorized distributors have paused commercial distribution of bebtelovimab until further notice.

Health care providers should use other approved or authorized products that are expected to retain activity against BQ.1 and BQ.1.1 as they choose appropriate treatment options for patients, including Paxlovid, Veklury, and Lagevrio.

Emergency Use Authorization of Bebtelovimab

Bebtelovimab is not currently authorized in any U.S. region due to the high frequency of circulating SARS-CoV-2 variants that are non-susceptible to bebtelovimab. Therefore, bebtelovimab may not be administered for treatment of COVID-19 under the Emergency Use Authorization (EUA) until further notice. Information about circulating variants can be found through Nowcast data.

Bebtelovimab Product Replacement Initiative

ASPR has paused the fulfillment of any pending requests under its Bebtelovimab Product Replacement Initiative due to bebtelovimab not currently being authorized for use in the U.S.

HPOP Reporting for Bebtelovimab

Note that reporting inventory and administration of all U.S. government-procured and distributed supply of bebtelovimab remains a requirement until all U.S. government-procured bebtelovimab is consumed (a provider site’s inventory is depleted).

Bebtelovimab Shelf-Life Extension and Retention

Shelf-life extensions were issued for specific lots of bebtelovimab. The U.S. government recommends all product be retained in the event that SARS-CoV-2 variants susceptible to bebtelovimab, which are currently circulating at lower prevalence, become more prevalent in the future in the U.S. Retained product must be appropriately held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers and the Letter of Authorization for Bebtelovimab.

Bebtelovimab FDA EUA Resources

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