Horizon scanning: US FDA panel recommends approval of canagliflozin for type 2 diabetes

Source: BioSpace Area: News According to BioSpace, the Endocrinologic and Metabolic Drugs Advisory Committee of the US FDA has voted 10-5 to recommend the approval of canagliflozin for the treatment of type 2 diabetes in adults.   Canagliflozin is a selective sodium glucose co-transporter 2 (SGLT2) inhibitor that works by blocking the reabsorption of glucose by the kidney, thus increasing glucose excretion and lowering blood glucose levels.  People with type 2 diabetes reabsorb greater amounts of glucose than those without diabetes, and this may contribute to elevated glucose levels. The advisory committee considered data from the global Phase III clinical program, which enrolled 10,285 patients in nine studies (both placebo- and active-controlled).   The FDA will consider the advisory committee recommendation in its review of the New Drug Application (NDA) for canagliflozin that was submitted by Janssen in May 2012.
Source: NeLM - News - Category: Drugs & Pharmacology Source Type: news