June 28, 2016 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee: First Panel To Weigh CV Benefit Claims:

 FDA's Endocrinologic and Metabolic Drugs Advisory Committee will meet June 28, 2016 to discuss the sNDAs for Jardiance and Synjardy (empagliflozin/metformin) for CV benefit claims

An FDA advisory panel will vote Tuesday on whether Eli Lilly and Co.'s and Boehringer Ingelheim's diabetes drug Jardiance, or empagliflozin, reduces the risk of cardiovascular death and on whether the drug should be labeled as such.

The meeting will mark the first advisory committee review of an outcomes trial conducted pursuant to FDA's December 2008 guidance on CV safety assessments for type 2 diabetes drugs that purported to demonstrate a CV benefit.

Helene D. Clayton-Jeter, O.D.
Office of Health and Constituent Affairs
Food and Drug Administration

For more information about the Cardiovascular & Endocrine Liaison Program visit the FDA Patient Network