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Janssen Research & Development Submits New Drug Application to U.S. FDA for Canagliflozin/Metformin Fixed-Dose Combination Therapy to Treat Patients with Type 2 Diabetes
Date:12/12/2012

ectrum of type 2 diabetes and included placebo- and active comparator-controlled studies. The program also includes a study in patients who have or are at high risk for developing cardiovascular disease, called the CANagliflozin cardioVascular Assessment Study (CANVAS).

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.

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

About 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. People with type 2 diabetes reabsorb greater amounts of glucose back into the body compared to non-diabetic people, which may contribute to elevated glucose levels. 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.

If left uncontrolled, type 2 diabetes can lead to serious long-term microvascular complications such as nerve disease leading to amputation, retinopathy resulting in blindness and nephropathy causing end-stage renal disease. Improved gl
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SOURCE Janssen Research & Development, LLC
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