Janssen files NDA with FDA for canagliflozin in type 2 diabetes

Janssen Research & Development, a subsidiary of health care giant Johnson & Johnson (NYSE: JNJ) has submitted a New Drug Application to the US Food and Drug Administration seeking approval for the use of canagliflozin, an investigational, oral, once-daily, selective sodium glucose co-transporter 2 (SGLT2) inhibitor, for the treatment of adult patients with type 2 diabetes.

The filing is supported by a comprehensive global Phase III clinical development program, which included nine multicenter, randomized 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 canagliflozin 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.