The U.S. Food and Drug Administration said on Sept. 16 it has revised the FDA’s emergency use authorization for Eli Lilly’s Covid-19 antibody cocktail to include for use in patients who have been exposed to the virus and are at high risk for progression to severe disease.
Eli Lilly said on Sept. 15 the U.S. government bought 388,000 additional doses of the company’s Covid-19 antibody therapy and Regeneron Pharmaceuticals said on Sept. 14 the U.S. government was buying 1.4 million additional doses of the Covid-19 antibody cocktail REGEN-COV., as infections surge due to the fast-spreading Delta variant.
Eli Lilly requested cancellation of the U.S. authorization granted to the company’s Covid-19 antibody bamlanivimab, which will now be used in combination with another to achieve greater efficacy against emerging virus variants.
Antibody treatments from Eli Lilly and Vir Biotechnology reduced viral load in low-risk Covid-19 patients, results from a mid-stage trial showed on March 29.
Europe’s drug regulator said on March 11 it had initiated a rolling review of U.S.-based Eli Lilly’s antibodies to treat Covid-19, days after saying their combination could be used in patients at high risk of progressing to severe illness.
Newly announced data from Eli Lilly’s Phase III BLAZE-1 clinical trial show a combination of two of the company’s monoclonal antibodies, bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016), significantly reduced the risk of hospitalization and death in high-risk patients with newly diagnosed coronavirus disease 2019.
Drugmaker Eli Lilly said on Feb. 26 the U.S. government agreed to buy at least 100,000 doses of the company’s newly authorized COVID-19 dual antibody cocktail for $210 million, with doses to be delivered through March-end.
The U.S. Food and Drug Administration granted Emergency Use Authorization (EUA) to a combination of Eli Lilly and AbCellera’s monoclonal antibody bamlanivimab and the Lilly antibody etesevimab for mild to moderate Covid-19.