FDA authorizes Eli Lilly's second COVID-19 antibody therapy, bebtelovimab

Eli Lilly announced this Friday that the FDA has issued an Emergency Use Authorization (EUA) for its second COVID-19 antibody therapy, bebtelovimab, for the treatment of high-risk patients with mild to moderate COVID-19 (≥ 12 years), and there are no effective treatment options for these patients
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The data supporting FDA approval of bebtelovimab are primarily based on the Phase II BLAZE-4 trial
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Daniel Skovronsky, the company's chief scientific and medical officer, noted that "researchers at Eli Lilly and Company have been studying bebtelovimab since early last year as a broadly neutralizing antibody against highly mutated variants.

BLAZE-4 (NCT04634409) is a randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of bamlanivimab alone and with other neutralizing antibodies versus placebo in the treatment of symptomatic COVID-19
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