FDA has cleared Biolojic Design’s IND for BD200, a bispecific antibody-drug conjugate targeting Trop2 and Nectin-4 whose arms can each bind either target. A global Phase 1 study in solid tumors is expected to begin in the coming weeks.
|Articles|February 11, 2021
FDA Grants Emergency Use Authorization to Eli Lilly COVID-19 Antibody Cocktail
Author(s)BioPharm International Editors
The EUA is based on positive results from a Phase III trial that showed bamlanivimab and etesevimab together reduced the risk of COVID-19 hospitalizations and death by 70%.
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Eli Lilly announced on Feb. 9, 2021 that FDA has granted emergency use authorization (EUA) to bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016), Eli Lilly’s antibody cocktail for the treatment of mild to moderate COVID-19 in patients ages 12 and older who are at high risk for progressing to severe COVID-19 or hospitalization.
The EUA is based on positive results from a Phase III trial that showed bamlanivimab and etesevimab together reduced the risk of COVID-19 hospitalizations and death by 70%, Eli Lilly said in a company press release. The antibodies are administered via a single intravenous infusion after a positive COVID-19 test and within 10 days of symptom onset.
"Lilly has dedicated our time, resources, and expertise to discover and develop therapies to treat COVID-19," said Daniel Skovronsky, MD, PhD, Eli Lilly's chief scientific officer and president of Lilly Research Laboratories, in the press release. "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. Additionally, with the risk of resistance emerging as various strains of the virus arise, bamlanivimab and etesevimab together could potentially allow efficacy against a broader range of naturally occurring SARS-CoV-2 variants as these new strains spread around the world."
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