Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for the company’s investigational neutralizing antibody bamlanivimab (LY-CoV555) 700 mg for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients, according toa press release.
Lilly said the FDA authorized Bamlanivimab for patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kilograms (about 88 pounds), and 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, Lilly said. 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.
Lilly will begin shipping bamlanivimab immediately to AmerisourceBergen, a national distributor, which will distribute it as directed by the U.S. government, which has purchased 300,000 doses of bamlanivimab.
Lilly anticipates manufacturing up to one million doses of bamlanivimab 700 mg by the end of 2020, for use around the world through early next year. Beginning in Q1 2021, the supply of Lilly's antibody therapy is expected to increase substantially, as additional manufacturing resources come online throughout the year.
