An NDA for TA 2784 (Jansssen Pharmaceuticals Inc.) is submitted to the FDA for Type 2 Diabetes

Janssen Pharmaceuticals Inc. (formerly Ortho McNeil) has submitted a New Drug Application (NDA) to the FDA seeking approval for the use of TA 2784 (canagliflozin) for the treatment of adult patients with Type 2 Diabetes. The filing is supported by a global Phase III clinical program which included nine multicentre, randomised clinical studies that enrolled approximately 10,300 patients, representing the largest late-stage development program for an investigational pharmacologic product for the treatment of patients with Type 2 Diabetes submitted to health authorities to date. The Phase III program evaluated the safety and efficacy of TA 7284 across the spectrum of Type 2 Diabetes and included placebo- and active comparator-controlled studies. The program also included a dedicated cardiovascular study conducted in patients who have or are at high risk for developing cardiovascular disease. Janssen will present data from the Phase III studies at future scientific venues, beginning with the Scientific Sessions of the American Diabetes Association in Philadelphia, in June.