INDIANAPOLIS — The U.S. Food and Drug Administration on Monday granted emergency use authorization to Eli Lilly and Company's experimental COVID-19 antibody treatment bamlanivimab.
According to a statement from the company, the drug 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.
Lilly said in a statement the drug 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.
"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," David A. Ricks, Lilly's chairman and CEO, said. "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."
The emergency use authorization 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 the drug showed reduced viral load and rates of symptoms and hospitalization, Lilly said in the statement.
Infusion reactions and other allergic hypersensitivity events have been reported, Lilly said. The emergency use authorization includes a warning for hypersensitivity including anaphylaxis and infusion-related reactions.
Lilly said the drug is not authorized for use in patients who are hospitalized due to COVID-19 or who require oxygen therapy due to COVID-19 or who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity.
"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," Daniel Skovronsky, M.D., Ph.D., Lilly's chief scientific officer and president of Lilly Research Laboratories, said. "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."