CHMP recommends Invokana for Type 2 Diabetes

Janssen-Cilag International NV (Janssen) announced that on 20 September 2013, the Committee for Medicinal Products for Human Use (CHMP) has granted a positive opinion recommending approval of Invokana (canagliflozin) in the European Union for the treatment of adults with Type 2 Diabetes mellitus, to improve glycaemic control. Canagliflozin is an oral, once-daily medication, which belongs to a new class of medications called sodium glucose co-transporter 2 (SGLT2) inhibitors.

The Marketing Authorisation Application submission was supported by a comprehensive global Phase III clinical programme, which enrolled more than 10,300 patients in nine studies, and is one of the largest late-stage development programmes for an investigational pharmacological product for the treatment of Type 2 Diabetes submitted to health authorities to date. Three studies compared canagliflozin to current standard treatments; two of which compared canagliflozin to sitagliptin and the other to glimepiride. The Phase III programme also included three large studies in special populations; older patients with Type 2 Diabetes, patients with Type 2 Diabetes who had moderate renal impairment, and patients with Type 2 Diabetes who were considered to be at high risk for cardiovascular disease.