Janssen receives CHMP recommendation for new diabetes drug

Janssen has announced that its new type 2 diabetes mellitus therapy Invokana has been recommended for European regulatory approval.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has endorsed the drug as a means of improving glycaemic control among sufferers of the disease.

Janssen's marketing authorisation application submission for Invokana was supported by a comprehensive global phase III clinical programme that enrolled more than 10,300 patients across nine studies, making it one of the largest late-stage development programmes ever for a diabetes drug.

Results for these studies have demonstrated the safety and efficacy of the product, which has already been approved for sale in the US on this basis.

Jane Griffiths, chairman for Janssen in Europe, the Middle East and Africa, said: "If approved, Invokana will pave the way for Janssen as part of our goal to develop and provide new therapeutic options for adult patients with type 2 diabetes."

This comes after the firm filed for EU and US approval of its new multicentric Castleman disease therapy siltuximab earlier this month.