Janssen submits diabetes drug for European approval

Janssen has submitted a European Medicines Agency marketing authorisation application for canagliflozin, its new treatment for type 2 diabetes.

The investigational once-daily sodium glucose co-transporter 2 inhibitor is designed as an oral therapy for adult patients and has had its safety and efficacy confirmed by a comprehensive global phase III clinical trial programme.

Involving around 10,300 patients, it was the largest late-stage development programme for an investigational type 2 diabetes drug ever submitted to health authorities, showcasing the benefits of the drug compared to placebo and alternative therapies.

Janssen holds the rights to canagliflozin in a number of key territories thanks to a licence agreement with Mitsubishi Tanabe Pharma.

The company said it is "confident in the value of the comprehensive clinical trial programme of canagliflozin" supporting the marketing authorisation application, though it does not wish to comment on the outcome of the regulatory procedure before it is complete.

Earlier this month, Janssen also submitted its oncology therapy Zytiga to regulators in Europe and the US for approval in an expanded indication for prostate cancer patients.