The FDA granted emergency use authorization Feb. 9 to Eli Lilly's COVID-19 antibody cocktail, a combination of antibodies bamlanivimab and etesevimab.
The antibody cocktail, which is administered via a single intravenous infusion, is authorized to treat mild to moderate COVID-19 in patients ages 12 and older who are at high risk for severe COVID-19 or hospitalization. The FDA said the antibody cocktail is not authorized to use in patients who are hospitalized or require oxygen therapy due to COVID-19.
The agency granted emergency use authorization to bamlanivimab Nov. 9. The new approval is based on phase 3 trial data that showed that administering bamlanivimab in combination with etesevimab reduced the risk of COVID-19 hospitalization and death by 70 percent.
"Bamlanivimab alone under emergency use authorization has already provided many people with an early treatment option that could prevent hospitalizations and we are excited to now add an additional therapeutic option with a similar demonstrated clinical benefit," Daniel Skovronsky, MD, PhD, the chief scientific officer and president of Eli Lilly's research laboratories, said in a news release.
The drugmaker said it plans to manufacture up to 1 million doses of the antibody cocktail in collaboration with Amgen by midyear.
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