FDA Grants EUA to Lilly's Bebtelovimab to Treat Mild-to-Moderate COVID-19
This decision was based from the analysis of the company’s phase 2 BLAZE-4 trial.
The Food and Drug Administration (FDA) has given Eli Lilly an Emergency Use Authorization (EUA) for its therapy, bebtelovimab, to treat patients with mild-to-moderate COVID-19.
"With the emergence of variants such as Omicron, treatment options remain limited,” Daniel Skovronsky, M.D, PhD, Lilly's chief scientific and medical officer, and president of Lilly Research Laboratories, said. “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 this EUA is based from the results of the company’s phase 2 BLAZE-4 trial. This trial was a randomized, clinical trial evaluating 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 Omicron and BA.2 variants.
Lilly’s bebtelovimab is an investigational neutralizing IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2 that maintains binding and neutralizing activity across currently known and reported variants.
This FDA EUA comes one day after the US federal government and Lilly came to an agreement for the latter to supply the former with up to 600,000 doses of the therapy, contingent upon the company receiving an EUA.
The agreement calls for Lilly to deliver those aforementioned doses no later than March 31 of this year, and comes with an option to provide up to another 500,000 doses no later than July 31.