Janssen-Cilag International (Janssen) has received approval from the European Commission (EC) for use of Vokanamet in the European Union (EU) as a treatment for adults with type 2 diabetes mellitus to improve glycaemic control.
Vokanamet is a fixed-dose therapy that combines canagliflozin and immediate release metformin hydrochloride in a single tablet.
In November 2013, canagliflozin as a single agent was approved as Invokana in the EU.
The approval follows a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending the approval of canagliflozin and immediate release metformin hydrochloride fixed dose combination therapy in February.
The combination therapy is taken as a single pill twice-daily and is indicated for adults aged 18 years and older with type 2 diabetes mellitus.
Rudolfstiftung Hospital’s Department of Medicine professor Guntram Schernthaner said approval of Vokanamet in the EU is 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," Schernthaner said.
Approval of the fixed-dose combination drug was based on significant portions of the comprehensive global Phase III clinical development programme for canagliflozin single agent, including the studies with co-administration of metformin and canagliflozin as individual tablets.
Janssen group chairman of Europe, Middle East, and Africa Jane Griffiths said: "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 Phase III programme assessed the safety and efficacy of canagliflozin across the spectrum of type 2 diabetes and included placebo and active comparator controlled studies.
In this programme, three studies have compared canagliflozin with existing standard treatments, with two comparing canagliflozin to sitagliptin as dual therapy with metformin and the other as triple therapy with metformin and sulphonylurea.
In addition, there is a study comparing canagliflozin to glimepiride as dual therapy with metformin.