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www.fdanews.com/articles/201843-eli-lillys-covid-19-antibody-therapy-slashes-risk-of-hospitalization-and-death

Eli Lilly’s COVID-19 Antibody Therapy Slashes Risk of Hospitalization and Death

March 11, 2021

Eli Lilly said its combination antibody therapy, bamlanivimab and etesevimab, reduced the risk of hospitalization and death by 87 percent in a late-stage study of 769 high-risk COVID-19 patients — and worked against emerging variant strains of the coronavirus.

Results observed over several months as new strains of the SARS-CoV-2 virus emerged “indicate bamlanivimab with etesevimab maintain [their] effects against a range of variants, particularly those circulating in the U.S.,” said Daniel Skovronsky, chief scientific officer and president of Lilly Research Laboratories.

The phase 3 trial, which enrolled patients with mild-to-moderate COVID-19, adds to findings from a separate phase 3 cohort reported in January. The previous phase 3 data, derived from more than 1,000 high-risk COVID-19 patients, indicated that the combination therapy reduced the risk of hospitalization or death by 70 percent.

“Across the two phase 3 cohorts of the study that have been analyzed to date, there have been no deaths in patients receiving treatment with bamlanivimab and etesevimab together, and 14 deaths in patients receiving placebo, 13 of which were deemed COVID-19-related,” the company said, adding that the safety profile of bamlanivimab and etesevimab together was consistent with those observed in other trials.

The combination antibody therapy received FDA Emergency Use Authorization in February and also drew a positive opinion from the European Medicines Agency (DID, March 8), paving the way for an EU conditional marketing authorization.

Also, in February, the U.S. government struck a $210 million deal to purchase 100,000 doses of the antibody cocktail, for delivery by March 31, with an option for 1.1 million more doses by November (DID, March 1). ― Jason Scott