The FINANCIAL -- Janssen-Cilag International NV announced that it 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 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 active comparator-controlled studies.

According to Johnson & Johnson, the programme also included a dedicated cardiovascular study conducted in patients who have or ar e at high risk for developing cardiovascular disease. Janssen has presented and will continue to present data from the Phase III studies at scientific meetings. On May 31, 2012 Janssen also submitted a New Drug Application for canagliflozin to the Food and Drug Administration (FDA) for a similar indication.

Canagliflozin is an investigational, oral, once-daily sodium glucose co-transporter 2 (SGLT2) inhibitor for the treatment of adult patients with type 2 diabetes. The kidneys of 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. Canagliflozin has been shown to block the reabsorption of glucose by the kidney, increasing glucose excretion and lowering blood glucose levels.

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

Janssen is confident in the value of the comprehensive clinical trial programme of canagliflozin supporting the MAA to the EMA. However, the company cannot speculate on the outcome of this regulatory procedure whilst it is ongoing.

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