The FDA has authorized Lilly’s investigational neutralizing antibody for COVID-19 treatment in the outpatient setting.
The FDA granted emergency use authorization (EUA) to bamlanivimab (LY-CoV555), Eli Lilly’s investigational neutralizing antibody for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19).
The agency has authorized bamlanivimab 700 mg to treat recently diagnosed, mild-to-moderate COVID-19 in high-risk patient populations 12 years of age and older. The US government has purchased 300,000 doses of bamlanivimab for high-risk patients, with no out-of-pocket costs; however, health care facilities may charge a fee for administering the treatment.
"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."
The EUA designation was based on results from Lilly’s BLAZE-1 trial showing that early intervention with bamlanivimab produced reduced viral load and rates of symptoms and hospitalization in the outpatient setting. Bamlanivimab, which is administered via a single intravenous infusion, should be given as soon as possible after a positive COVID-19 test, and within 10 days of symptom onset.
“Lilly will begin shipping bamlanivimab immediately to AmerisourceBergen…which will distribute it as directed by the US government’s allocation program,” Lilly’s news release said.
In regard to distribution of the COVID-19 treatment in the US, the federal government intends on weekly allocation decisions based on confirmed COVID-19 cases in each state and territory through data projected by the US Department of Health and Human Services’ (HHS) Protect data collection platform.
Through national and international distribution of LY-CoV555, Lilly expects to manufacture up to 1 million doses by the end of 2020.