Janssen files for EU approval of canagliflozin in type 2 diabetes; Ferrer pulls Egrifta MAA

US health care giant Johnson & Johnson’s (NYSE: JNJ) European subsidiary Janssen-Cilag International NV (Janssen) has submitted a Marketing Authorisation Application to the European Medicines Agency 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.

Janssen and its affiliates have rights to canagliflozin through a license agreement with Japan’s Mitsubishi Tanabe Pharma (TYO: 4508) in North America, South America, Europe, the Middle East, Africa, Australia, New Zealand and parts of Asia. J&J recently filed a New Drug Application for the product in the USA for a similar indication (The Pharma Letter June 1).

The MAA submission for canagliflozin is supported by a comprehensive global Phase III clinical development program, which included nine multicenter, randomized clinical studies that enrolled around 10,300 patients, representing the largest late-stage development program for an investigational pharmacologic product for the treatment of adult patients with type 2 diabetes submitted to health authorities to date.