Eli Lilly announced that new data from the randomized, double-blind, placebo-controlled BLAZE-1 Phase 3 study, demonstrating bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg together significantly reduced COVID-19 related hospitalizations and deaths in high-risk patients recently diagnosed with COVID-19. These results provide additional efficacy and safety data that support the use of the dose recently granted both Emergency Use Authorization by the U.S. Food and Drug Administration (FDA) and a positive scientific opinion by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).
The new study included 769 high-risk patients, aged 12 and older with mild to moderate COVID-19. Around 511 patients received the therapy and 258 received a placebo. The data revealed that a combination of bamlanivimab 700 mg and etesevimab 1400 mg reduced the risk of hospitalizations and death by 87 percent. The combo scored its emergency nod last month on the heels of the earlier data. Lilly has partnered with Amgen to help produce up to 1 million doses of the cocktail this year.
The previous Phase 3 cohort, bamlanivimab 2800 mg with etesevimab 2800 mg reduced the risk of hospitalizations and deaths by 70 percent. In this new Phase 3 cohort, there was four deaths total, all of which were deemed related to COVID-19 and all of which occurred in patients taking placebo; no deaths occurred in patients receiving treatment with bamlanivimab and etesevimab together. Bamlanivimab and etesevimab together and bamlanivimab alone are not authorized for patients hospitalized due to COVID-19 or patients who require oxygen therapy due to COVID-19.