Eli Lilly's Investigational Monoclonal Antibody Therapy Bamlanivimab Granted FDA EUA for Treatment of COVID-19

Eli Lilly and Company’s (Indianapolis, Ind, USA) investigational neutralizing antibody bamlanivimab (LY-CoV555) 700 mg has been granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for the treatment of recently diagnosed COVID-19.

Bamlanivimab is authorized for the treatment of mild to moderate COVID-19 in adults and pediatric patients 12 years and older with a positive COVID-19 test, who are at high risk for progressing to severe COVID-19 and/or hospitalization. Bamlanivimab should be administered as soon as possible after a positive COVID-19 test and within 10 days of symptom onset. The authorization allows for the distribution and emergency use of bamlanivimab, which is administered via a single intravenous infusion.

The EUA is based on data from BLAZE-1, a randomized, double-blind, placebo-controlled Phase 2 study in patients with recently diagnosed mild to moderate COVID-19 in the outpatient setting. Patients treated with bamlanivimab showed reduced viral load and rates of symptoms and hospitalization. In BLAZE-1, frequency and types of adverse events were similar between bamlanivimab and placebo, with the majority being mild to moderate in severity. Infusion reactions and other allergic hypersensitivity events have been reported. The EUA includes a warning for hypersensitivity including anaphylaxis and infusion-related reactions.

"The BLAZE-1 data show bamlanivimab, when given early in the disease course, may help patients clear the virus and reduce COVID-related hospitalizations, supporting our belief that neutralizing antibodies can be an important therapeutic option for patients fighting this virus," said Daniel Skovronsky, M.D., Ph.D., Lilly's chief scientific officer and president of Lilly Research Laboratories. "We're proud of the speed with which we have been able to bring patients this therapy specifically designed to treat COVID-19. We thank those who have contributed to this medical advancement, particularly the clinical trial investigators and participants around the country."

"This emergency authorization allows us to make bamlanivimab available as a COVID-19 treatment for recently diagnosed, high-risk patients – adding a valuable tool for doctors fighting the now-increasing burden of this global pandemic," said David A. Ricks, Lilly's chairman and CEO. "The rapid development and availability of bamlanivimab could not have been achieved without the relentless work of our Lilly team, collaboration across the industry and the urgent work being done by the government to ensure appropriate allocation to patients who need it the most."

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