Immunology

Janssen-Cilag International NV (Janssen) announced today that the European Commission (EC) has approved VOKANAMET^® (a fixed-dose therapy combining canagliflozin and immediate release metformin hydrochloride in a single tablet) in the European Union, for the treatment of adults with type 2 diabetes mellitus to improve glycaemic control. Canagliflozin as a single agent was approvedas INVOKANA^® in the European Union in November 2013.

This EC decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), recommending the approval of canagliflozin and immediate release metformin hydrochloride fixed dose combination therapy, in February 2014. The combination therapy, which is taken as a single pill twice daily, is indicated in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control in:

• patients not adequately controlled on their maximally tolerated doses of metformin alone;
• patients on their maximally tolerated doses of metformin along with other glucose-lowering medicinal products including insulin, when these do not provide adequate glycaemic control;
• patients already being treated with the combination of canagliflozin and metformin as separate tablets;

Professor Guntram Schernthaner, Department of Medicine I, Rudolfstiftung Hospital, Austria comments, "The approval of VOKANAMET^® in the European Union is very welcome news for the growing number of people with type 2 diabetes in this region. Many patients struggle to achieve and maintain long-term glycaemic control, and the introduction of VOKANAMET^® provides added convenience to diabetes management, particularly to those patients who may benefit from two diabetes medications in one tablet."

Commenting on the approval, Jane Griffiths, Company Group Chairman, Janssen Europe, Middle East, and Africa said, "We are delighted that the European Commission has approved VOKANAMET^® for use in the European Union, recognising the value and the convenience that this combined treatment option provides for patients. This approval further reinforces Janssen's ongoing commitment to provide new therapeutic options that help to address unmet needs in the treatment of type 2 diabetes."

The EC approval of this fixed-dose therapy combining canagliflozin and immediate release metformin hydrochloride in a single tablet taken twice daily was based on significant portions of the comprehensive global Phase 3 clinical development programme for canagliflozin single agent, including the studies with co-administration of metformin and canagliflozin as individual tablets.