FDA CV Requirements Sideline Sanofi’s Lixisenatide
This article was originally published in The Pink Sheet Daily
Executive Summary
Sanofi will withdraw its NDA for the GLP-1 agonist for diabetes to await the final results of an ongoing cardiovascular outcomes trial. The decision could delay a U.S. launch of lixisenatide by three years.
You may also be interested in...
Sanofi's Lixisenatide Shows Challenges Of Being Late Entrant In Class
Safety and efficacy of what would be sixth GLP-1 agonist seem solid, but FDA advisory committee notes concerns about allergic reactions, dosing and relative effectiveness.
Keeping Track: Sanofi Submits Lixisenatide NDA (Again); Sandoz Files Second Biosimilar Application
The latest drug development news and highlights from our FDA Performance Tracker.
Sanofi's Lixisenatide Gets Clean Bill Of Health On CV Safety, Heart Failure
ELIXA trial results show neither increased nor decreased risk of major adverse cardiovascular events; Sanofi's diabetes drug, still unapproved in the U.S., becomes the only GLP-1 receptor agonist with CV outcomes data.