Jardiance Mortality Claim Narrowly Endorsed By FDA Advisory Committee
This article was originally published in The Pink Sheet Daily
The 12-11 vote supporting new indication for reduced incidence of cardiovascular death provides cover for FDA if it decides more data are needed before granting first CV benefit claim to a diabetes drug.
You may also be interested in...
Boehringer wants supplemental empagliflozin claim as insulin adjunct to improve glycemic control in type 1 diabetes, but US FDA questions the size of the clinical benefit and the magnitude of a diabetic ketoacidosis risk.
Endocrinologic and Metabolic Drugs Advisory Committee will reconsider 2008 guidance on evaluating CV risks in antidiabetic therapies at two-day meeting in October.
US FDA does not raise any major concerns about study’s design or results to support cardiovascular risk reduction claim for Novo Nordisk’s GLP-1 agonist liraglutide ahead of advisory committee, but agency gives close scrutiny to non-CV safety events of interest.