Janssen Submits European Marketing Authorisation Application for Canagliflozin in Type 2 Diabetes

Janssen Submits European Marketing Authorisation Application for Canagliflozin in Type 2 Diabetes PR Newswire BEERSE, Belgium, June 26, 2012 BEERSE, Belgium, June 26, 2012 /PRNewswire/ -- Janssen-Cilag International NV (Janssen) announced today that it has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for the use of canagliflozin, an investigational, oral, once-daily sodium glucose co-transporter 2 (SGLT2) inhibitor, for the treatment of adult patients with type 2 diabetes. The MAA submission for canagliflozin is supported by a comprehensive global Phase III clinical development programme, which included nine multicentre, randomised clinical studies that enrolled approximately 10,300 patients, representing the largest late-stage development programme for an investigational pharmacologic product for the treatment of adult patients with type 2 diabetes submitted to health authorities to date. The Phase III programme evaluated the safety and efficacy of canagliflozin across the spectrum of adult patients with type 2 diabetes and included placebo- and [1]active comparator-controlled studies. The programme also included a dedicated cardiovascular study conducted in patients who have or are at high risk for developing cardiovascular disease. Janssen has presented and will continue to present data from the Phase III studies at scientific [i,ii,iii,iv,v,vi,vii,viii]meetings.