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FDA Advisory Committee Recommends Approval Of Canagliflozin For Treatment Of Adults With Type 2 Diabetes

Canagliflozin was generally well tolerated. It has specific safety and tolerability issues that were well characterized in this development program (such as the genital mycotic infections, urinary tract infections) and can be well managed by the physician, and for some of these issues by the patient.

Janssen presented data from Phase 3 studies at the American Diabetes Association ( ADA) in Philadelphia in June, at the European Association for the Study of Diabetes ( EASD) in Berlin in October, and at the World Congress on Controversies to Consensus in Diabetes, Obesity, and Hypertension ( CODHy) in Barcelona in November.

The FDA will consider the advisory committee recommendation in its review of the New Drug Application (NDA) for canagliflozin that was submitted by Janssen on May 31, 2012, though the FDA is not bound to follow it. 

Janssen and its affiliates have rights to canagliflozin through a license agreement with Mitsubishi Tanabe Pharma Corporation. Janssen Pharmaceuticals, Inc. and its affiliates have marketing rights in North America, South America, Europe, the Middle East, Africa, Australia, New Zealand, and parts of Asia.

About Type 2 Diabetes

The ADA estimates that 26 million Americans have type 2 diabetes. Type 2 diabetes is a chronic condition that affects the body's ability to metabolize sugar, or glucose, and is characterized by the inability of pancreatic beta cell function to keep up with the body's demand for insulin. In most people with type 2 diabetes, obesity causes resistance of the body to the action of insulin, and if the pancreatic beta cell cannot produce enough insulin, hyperglycemia and type 2 diabetes ensue.

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