Vokanamet is a fixed-dose therapy combining canagliflozin and immediate release metformin in a single tablet.
Canagliflozin, a member of a new class of drugs known as sodium glucose co-transporter 2 (SGLT2) inhibitors, was approved in the EU in November 2013 for the treatment of adult patients with type 2 diabetes mellitus, to improve glycaemic control.
Since its EU approval, canagliflozin is available as Invokana. Invokana was approved in the US in March 2013.
Canagliflozin plays an important role in the kidney and contributes to controlling blood glucose levels. It selectively inhibits SGLT2, and, as a result, promotes the loss of glucose via the urine, lowering blood glucose levels in adults with type 2 diabetes.
Metformin, a first-line pharmacotherapy, can be used alone or with other medications, including insulin, to treat type 2 diabetes. The drug lowers blood glucose levels by decreasing the amount of glucose made by the liver, increasing insulin sensitivity in the muscle and delaying intestinal glucose absorption.
Significant portions of the clinical data in this marketing authorization application are derived from the Phase III clinical development program for canagliflozin single agent. The Phase III program assessed the safety and efficacy of canagliflozin across the spectrum of type 2 diabetes and included placebo and active comparator controlled studies.
Three studies have compared canagliflozin to current standard treatments, two of which compared canagliflozin to sitagliptin as triple therapy with metformin and sulphonylurea and the other to glimepiride as dual therapy with metformin.
Through a license agreement with Mitsubishi Tanabe Pharma, Janssen and its affiliates have rights to canagliflozin and have marketing rights in North America, South America, Europe, the Middle East, Africa, Australia, New Zealand and parts of Asia.
Rudolfstiftung Hospital, Austria Department of Medicine I Dr Guntram Schernthaner noted if approved, Vokanamet will offer an additional treatment option in the management of type 2 diabetes in Europe.
"Metformin as a first line therapy for type 2 diabetes has offered real hope for patients to achieve their treatment goals. The potential of combining canagliflozin’s mode of action with metformin provides an exciting approach to diabetes management, offering patients the benefits of blood glucose and body weight reduction without increasing the risk for hypoglycaemia," Dr Schernthaner added.