The Endocrinologic and Metabolic Drugs Advisory Committee met on July 19, 2011 to discuss the safety and efficacy of dapagliflozin as a treatment for type 2 diabetes mellitus (T2DM).

Overall, the committee voted negatively on whether to recommend dapagliflozin for approval. Six members voted in favor and nine voted against approval, but more reasoned comments regarding the major safety issue were more evenly split, with one member noting she could have voted either way on the need for pre-marketing resolution.

Included in this PDF document are our analyses of the committee meeting and the briefing documents. We also are providing a breakdown of how each panel member voted as well as his/her comments during the discussion session. Additionally, we are providing a calendar of upcoming catalysts for the type 2 diabetes market.

For the full report, please download the PDF version at the top of this page.

For our disclosures, please read the BioMedTracker Research Standards.