Janssen submits new diabetes therapy for EU approval

Janssen has announced the submission of a marketing authorisation application to the European Medicines Agency for a new combination diabetes therapy.

The company is seeking approval for a fixed-dose therapy combining canagliflozin and immediate-release metformin to treat adult patients with type 2 diabetes, based on positive phase III trial data supporting the therapy's safety and efficacy.

Canagliflozin is an investigational oral medication that functions by blocking the reabsorption of glucose by the kidney, thus increasing glucose excretion and lowering blood glucose levels, while metformin decreases the amount of glucose made by the liver to increase insulin sensitivity in the muscle and delay intestinal glucose absorption.

Janssen said: "If approved, this canagliflozin/metformin fixed-dose combination therapy could provide convenience for patients who may benefit from two diabetes medications working in one pill."

In January 2013, the company received European regulatory approval for its drug Zytiga as a treatment for metastatic castration-resistant prostate cancer.