FDA CV Requirements Sideline Sanofi’s Lixisenatide
This article was originally published in The Pink Sheet Daily
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.
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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.