By William Elliott, MD, FACP, and James Chan, PharmD, PhD
Dr. Elliott is Assistant Clinical Professor of Medicine, University of California, San Francisco.
Dr. Chan is Associate Clinical Professor, School of Pharmacy, University of California, San Francisco.
The FDA has issued an emergency use authorization (EUA) for a monoclonal antibody to treat COVID-19. Bebtelovimab (BEB) is a recombinant neutralizing human IgG1k monoclonal antibody to the spike protein of SARS-CoV-2. BEB is active against the omicron variant and the BA.2 omicron subvariant.1
Under the EUA, BEB can be prescribed to treat mild-to-moderate COVID-19 in adults and pediatric patients (age 12 years and older weighing at least 40 kg).2
It is not authorized for patients who are hospitalized because of COVID-19, require oxygen therapy and/or respiratory support, require increase in baseline oxygen flow rate because of COVID-19, or on respiratory support for a non-COVID-19-related comorbidity.
The recommended dosage is 175 mg given as a single intravenous injection over at least 30 seconds.2 It should be given as soon as possible after positive viral test results and within seven days of symptom onset. BEB is available as a single-dose vial, each containing 175 mg/2 mL.
BEB was tested against full-length spike genes from different variants of SARS-CoV-2, retaining activity against earlier variants (e.g., delta) as well as omicron (BA.1 and the BA.2 subvariant).2
There are insufficient data regarding the effect of BEB on hospitalization and mortality outcomes.3 The mu variant showed reduced susceptibility to BEB.2 Serious hypersensitivity reactions, including anaphylaxis, have been reported.2 Clinical worsening of COVID-19 after the administration of SARS-CoV-2 monoclonal antibody treatment has been reported.2
The clinical data supporting the BEB EUA was based mainly on BLAZE-4, a phase II trial (NCT04634409).2 Researchers assessed the efficacy of BEB alone and together with bamlanivimab (BAM) and etesevimab (ETE; combo mAbs) vs. placebo. Nonvaccinated subjects who had contracted mild-to-moderate COVID-19 and who were low risk and high risk of progressing to severe disease were enrolled. In the low-risk group, subjects were randomized to combo mAbs or placebo. The primary endpoint was the proportion of subjects with persistently high viral load (> 5.27 log10) at day 7. Results were 21% for placebo, 13% for combo mAbs, and 14% for BEB. In the high-risk arm, BEB was compared to combo mAbs. The efficacy endpoint was COVID-19-related hospitalization (≥ 24 hours of acute care or all-cause mortality by day 29). Results were 4% BEB vs. 3% combo mAbs. The clinical study was conducted before the emergence of the omicron variant; these subjects were infected with delta (50%) and alpha (29%). There was no placebo arm in the high-risk study.2
The FDA concluded the totality of evidence, both clinical and nonclinical, support the effectiveness of BEB in mild-to-moderate COVID-19, with the strength of evidence coming from in vitro data and similarity in mechanism of action to other effective SARS-CoV-2 mAbs.2,3 The COVID-19 Treatment Guidelines Panel updated its treatment guidelines in earlier this month. Preferred therapies in order of preference are nirmatrelvir with ritonavir (Paxlovid), sotrovimab, and remdesivir. BEB and molnupiravir are considered alternative therapies if none of the preferred therapies are available, feasible to deliver, or clinically appropriate.3
- U.S Food & Drug Administration. Coronavirus (COVID-19) update: FDA authorizes new monoclonal antibody for treatment of COVID-19 that retains activity against omicron variant. Feb. 11, 2022.
- U.S. Food & Drug Administration. Fact sheet for healthcare providers: Emergency use authorization for bebtelovimab. Feb. 11, 2022.
- National Institutes of Health. The COVID-19 Treatment Guidelines Panel’s statement on the role of bebtelovimab for the treatment of high-risk, nonhospitalized patients with mild to moderate COVID-19. Page last reviewed on March 2, 2022.
The FDA has issued an emergency use authorization for a monoclonal antibody that demonstrated efficacy against the omicron variant of COVID-19.
Subscribe Now for Access
You have reached your article limit for the month. We hope you found our articles both enjoyable and insightful. For information on new subscriptions, product trials, alternative billing arrangements or group and site discounts please call 800-688-2421. We look forward to having you as a long-term member of the Relias Media community.