FDA Grants EUA for Lilly Antibody Cocktail
The US Food and Drug administration (FDA) has granted an Emergency Use Authorization (EUA) for the bamlanivimab-etesevimab antibody cocktail made by Eli Lilly for treatment of patients 12 and older who have mild to moderate cases of Covid-19 but are at risk of developing a severe form of the disease.
The authorization for the investigational combination of bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg follows the November 2020 EUA for the use of bamlanivimab alone in high-risk patients with mild to moderate cases of Covid.
Lilly, which is partnering with Amgen on manufacturing the cocktail, said the aim is to produce up to 1 million doses by mid-2021. Some 100,000 doses are available immediately, the company said, with an additional 150,000 doses expected to be ready by the end of the first quarter.
In a Phase 3 trial involving more than 1,000 high-risk patients with newly diagnosed Covid, Lilly said only 11 patients who received the combination infusion were hospitalized and none died, compared with 36 hospitalizations and 10 deaths among placebo patients. This, it said, translated into a 70% reduction in the risk of a Covid-19 hospitalization or death.
Along with the EUA, the US drugs watchdog authorized shorter infusion times for the cocktail (21 minutes) as well as for bamlanivimab alone (16 minutes) compared with the one hour of bamlanivimab tried previously. The change is said to be aimed at redcuing the burden on medical staff.
Apart from meeting the trial’s primary endpoint of cutting the risk of hospitalization or death, Lilly said the antibody mix also met secondary endpoints such as evidence of reduced viral load and improved resolution of symptoms.
Bamlanivimab alone is authorized in numerous countries, according to the Indiana- based pharma, which added that the cocktail also has been approved in Italy. Lilly said it will continue working with global regulators to make these therapies available around the world.
Separately, the drugmaker is also developing LY-CoV016 through a licensing deal with China’s Junshi Biosciences.
Author: Dede Williams, Freelance Journalist
