Another SARS-CoV-2 Monoclonal Antibody Authorization Revoked

The U.S. Food and Drug Administration (FDA) recently announced that Eli Lilly's monoclonal antibody Bebtelovimab is not currently authorized for emergency use in the U.S. because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1.

Bebtelovimab is an investigational medicine used to treat mild-to-moderate COVID-19 in adults and certain children.

Eli Lilly and its authorized distributors (AmerisourceBergen) have paused the commercial distribution of Bebtelovimab until further notice by the FDA.

Additionally, the Administration for Strategic Preparedness and Response has paused fulfilling any pending requests under its Bebtelovimab Product Replacement Initiative. 

The FDA stated on November 30, 2022, healthcare 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, which include Paxlovid, Veklury, and Lagevrio.

In addition, COVID-19 convalescent plasma with high titers of anti-SARS-CoV-2 antibodies is authorized to treat COVID-19 in patients with an immunosuppressive disease or receiving immunosuppressive treatments.

Other SARS-CoV-2 monoclonal antibody news is posted at PrecisionVaccinations.com/Antibodies.