Effectiveness of Bebtelovimab Against Hospitalization and Death From the Omicron BA.4/BA.5 and BQ.1/BQ.1.1 Subvariants.

On February 11, 2022, the US Food and Drug Administration issued Emergency Use Authorization for the monoclonal antibody bebtelovimab to treat mild-to-moderate COVID-19 in patients who were at high risk of progression to severe disease but could not receive other COVID-19 therapies. 1 Fact sheet for healthcare providers: emergency use authorization for bebtelovimab. February 2022. US Food and Drug Administration website. Accessed June 30, 2023. https://www.fda.gov/media/156152/download Google Scholar Bebtelovimab was shown to perform comparably to nirmatrelvir-ritonavir during the BA.2 omicron epoch. 2 Razonable R.R. O’Horo J.C. Hanson S.N. et al. Comparable outcomes for bebtelovimab and ritonavir-boosted nirmatrelvir treatment in high-risk patients with coronavirus disease-2019 during severe acute respiratory syndrome coronavirus 2 BA. 2 Omicron epoch. J Infect Dis. 2022; 226: 1683-1687 Crossref PubMed Scopus (16) Google Scholar On November 30, 2022, the US Food and Drug Administration withdrew its Emergency Use Authorization for bebtelovimab because the treatment was not expected to neutralize newer omicron subvariants. 3 Fact sheet for healthcare providers: emergency use authorization for bebtelovimab. November 2022. US Food and Drug Administration website. https://www.fda.gov/media/156152/downloadDate accessed: June 30, 2023 Google Scholar However, the clinical impact of bebtelovimab on the BA.4/BA.5 and BQ.1/BQ.1.1 subvariants was never investigated.