CHMP recommends approval of Vokanamet for T2D - Janssen

The CHMP has adopted a positive opinion, recommending marketing authorisation in the European Union for Vokanamet, a fixed-dose therapy combining canagliflozin and immediate release metformin in a single tablet, from Janssen, for the treatment of Type 2 Diabetes. Parts of the approval are based on a Phase III programme which evaluated 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. The programme also included two large studies in special populations: patients over 55 with Type 2 Diabetes and patients with Type 2 Diabetes who were considered to be at high risk for cardiovascular disease.