The Meals and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for bebtelovimab for the remedy of delicate to average COVID-19 in sufferers 12 years of age and older weighing at the very least 40kg with constructive outcomes of direct SARS-CoV-2 viral testing, and who’re at excessive danger for development to extreme COVID-19, together with hospitalization or dying, and for whom various COVID-19 remedy choices authorised or licensed by the FDA should not accessible or clinically applicable.
Bebtelovimab is a recombinant neutralizing human IgG1κ monoclonal antibody that works by binding to the spike protein of SARS-CoV-2. The EUA was supported by knowledge from the part 2 BLAZE-4 trial (ClinicalTrials.gov Identifier: NCT04634409), which evaluated the efficacy and security of bebtelovimab in nonhospitalized sufferers with delicate to average COVID-19. Sufferers obtained a single IV infusion of bebtelovimab 175mg alone or along with bamlanivimab 700mg and etesevimab 1400mg.
Amongst 380 low-risk sufferers enrolled within the placebo-controlled portion of the trial, remedy with bebtelovimab resulted in a discount in time to sustained symptom decision in contrast with placebo. The median time to sustained symptom decision was 7 days (95% CI, 6-8) for sufferers handled with bamlanivimab, etesevimab, and bebtelovimab collectively (P =.289) and 6 days (95% CI, 5-7) for sufferers handled with bebtelovimab alone (P =.003), in contrast with 8 days (95% CI, 7-9) for sufferers handled with placebo. There was additionally a discount in viral load noticed on day 5 after remedy in contrast with placebo.
Within the randomized, open-label portion of the trial, 150 high-risk sufferers had been handled with a single infusion of bebtelovimab alone or along with etesevimab and bamlanivimab. The proportion of sufferers with COVID-19 associated hospitalization or dying by any trigger was assessed by day 29. Outcomes confirmed occasions occurred in 2 sufferers handled with the mixture of bamlanivimab, etesevimab, and bebtelovimab and in 3 sufferers handled with bebtelovimab alone. One affected person handled with bebtelovimab alone died on day 34. The median time to sustained symptom decision was 7 days for sufferers handled with bebtelovimab alone.
Within the nonrandomized, open-label portion of the trial, 176 high-risk sufferers had been handled with a single infusion of bamlanivimab, etesevimab, and bebtelovimab. The proportion of sufferers with COVID-19 associated hospitalization or dying by any trigger was assessed by day 29. Occasions occurred in 3 sufferers with no deaths reported. The median time to sustained symptom decision was 8 days.
BLAZE-4 was carried out previous to the emergence of the Omicron variant; no sufferers within the examine had been contaminated with virus of the Omicron lineage or sublineages. Nonetheless, nonclinical viral neutralization knowledge confirmed that bebtelovimab retained full neutralizing exercise in opposition to Omicron and all different recognized variants of curiosity and concern, together with BA.2.
The commonest antagonistic reactions reported with bebtelovimab had been infusion-related reactions (0.3%), pruritus (0.3%), and rash (0.8%). Therapy with bebtelovimab can also be related to severe hypersensitivity reactions, together with anaphylaxis.
The licensed dose of bebtelovimab is 175mg administered as a single intravenous injection over at the very least 30 seconds. Bebtelovimab needs to be administered as quickly as attainable after constructive outcomes of direct SARS-CoV-2 viral testing and inside 7 days of symptom onset. The product is provided as a 175mg/2mL single-dose vial.
The well being care supplier reality sheet for bebtelovimab might be discovered here.
- Lilly’s bebtelovimab receives Emergency Use Authorization for the remedy of mild-to-moderate COVID-19. Information launch. Eli Lilly and Firm. February 11, 2022. Accessed February 14, 2022. https://www.prnewswire.com/news-releases/lillys-bebtelovimab-receives-emergency-use-authorization-for-the-treatment-of-mild-to-moderate-covid-19-301480923.html
- Coronavirus (COVID-19) replace: FDA authorizes new monoclonal antibody for remedy of COVID-19 that retains exercise in opposition to Omicron variant. Information launch. US Meals and Drug Administration. February 11, 2022. Accessed February 14, 2022. https://www.prnewswire.com/news-releases/coronavirus-covid-19-update-fda-authorizes-new-monoclonal-antibody-for-treatment-of-covid-19-that-retains-activity-against-omicron-variant-301480912.html
- AbCellera-discovered antibody, bebtelovimab, receives U.S. FDA Emergency Use Authorization for the remedy of mild-to-moderate COVID-19. Information launch. AbCellera. February 11, 2022. Accessed February 14, 2022. https://www.businesswire.com/news/home/20220211005524/en/AbCellera-Discovered-Antibody-Bebtelovimab-Receives-U.S.-FDA-Emergency-Use-Authorization-for-the-Treatment-of-Mild-to-Moderate-COVID-19
- Bebtelovimab reality sheet for well being care suppliers. Accessed February 14, 2022. http://pi.lilly.com/eua/bebtelovimab-eua-factsheet-hcp.pdf
This text initially appeared on MPR