FDA Grants EUA to Bebtelovimab for Mild-to-Moderate COVID-19 With High Risk of Progression

Bebtelovimab gets Emergency Use Authorization to treat mild-to-moderate COVID-19 in adults and pediatric patients who are at high risk for progression to severe COVID-19.

The FDA has awarded an Emergency Use Authorization (EUA) to bebtelovimab (Eli Lilly) for the treatment of patients with mild-to-moderate COVID-19.

The EUA allows the use of bebtelovimab to treat mild-to-moderate COVID-19 in adults and pediatric patients 12 years of age and older, who weigh at least 40 kg, who test positive on direct SARS-CoV-2 viral testing, who are at high risk for progression to severe COVID-19, and for whom alternative treatment options are not approved or authorized by the FDA or are not clinically appropriate. The approved dose of bebtelovimab is 175 mg administered as an intravenous injection over at least 30 seconds.

"With the emergence of variants such as Omicron, treatment options remain limited,” said Daniel Skovronsky, MD, PhD, Lilly chief scientific and medical officer, and president of Lilly Research Laboratories, in a press release. “Lilly is pleased to provide another treatment option to help address the ongoing needs of patients and health care providers who continue to battle this pandemic."

The data supporting the EUA is based on results from the phase 2 BLAZE-4 trial. The randomized clinical trial evaluated the treatment of non-hospitalized patients with mild-to-moderate COVID-19 who were treated with the authorized dose of bebtelovimab (175 mg) alone or together with 700 mg bamlanivimab and 1400 mg of etesevimab.

Pseudovirus and authentic virus testing demonstrated that bebtelovimab retains full neutralizing activity against the Omicron and BA.2 variants, according to the study. Bebtelovimab is an investigational neutralizing IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2, which maintains binding and neutralizing activity across currently known and reported variants.

The authorization was issued after the US federal government and Lilly agreed for the manufacturer to supply up to 600,000 doses of bebtelovimab contingent upon the EUA. As part of the agreement, Lilly will deliver the doses no later than March 31 2022, and it comes with an option to provide up to another 500,000 doses no later than July 31, 2022.

Reference

Lilly's bebtelovimab receives Emergency Use Authorization for the treatment of mild-to-moderate COVID-19. Eli Lilly. News release. https://investor.lilly.com/news-releases/news-release-details/lillys-bebtelovimab-receives-emergency-use-authorization. February 11, 2022. Accessed February 14, 2022.