The FDA has withdrawn its Emergency Use Authorization (EUA) of the investigational anti-SARS-CoV-2 monoclonal antibody bebtelovimab (LY-CoV1404 – Lilly) for treatment of COVID-19. Bebtelovimab is not expected to retain activity against the Omicron variants BQ.1, BQ.1.1, and XBB, which currently cause the majority of COVID-19 cases in all regions of the US.1-3
The NIH currently recommends treating high-risk nonhospitalized adults with COVID-19 with either oral ritonavir-boosted nirmatrelvir (Paxlovid) or IV remdesivir (Veklury); Paxlovid is preferred.4 Both of these therapies decreased the risk of hospitalization or death significantly more than placebo in large, randomized, double-blind trials.5,6 If these drugs are inappropriate or unavailable, use of oral molnupiravir (Lagevrio; available under an EUA) is recommended.4,7 Ritonavir-boosted nirmatrelvir, remdesivir, and molnupiravir are expected to retain activity against SARS-CoV-2 variants BQ.1, BQ.1.1, and XBB.1
- FDA. FDA announces bebtelovimab is not currently authorized in any US region. November 30, 2022. Available at: https://bit. ly/3hoAWER. Accessed January 5, 2023.
- CDC. COVID data tracker. Variant proportions. January 4, 2023. Available at: https://bit.ly/3Ka3HhH. Accessed January 5, 2023.
- M Imai et al. Efficacy of antiviral agents against omicron subvariants BQ.1.1 and XBB. N Engl J Med 2023; 388:89.
- NIH. COVID-19 treatment guidelines. Therapeutic management of nonhospitalized adults with COVID-19. December 28, 2022. Available at: https://bit.ly/3w5TdLB. Accessed January 5, 2023.
- J Hammond et al. Oral nirmatrelvir for high-risk, non-hospitalized adults with Covid-19. N Engl J Med 2022; 386:1397.
- RL Gottlieb et al. Early remdesivir to prevent progression to severe Covid-19 in outpatients. N Engl J Med 2022; 386:305.
- NIH. COVID-19 treatment guidelines. What's new in the guidelines. December 28, 2022. Available at: https://bit.ly/3GGHGHH. Accessed January 5, 2023.