Janssen-Cilag International NV, a division of Johnson & Johnson, received EC approval for Invokana (canagliflozin) in the EU for the treatment of adults with type 2 diabetes mellitus, to improve glycemic control. Canagliflozin is an oral, once-daily medication, performing as a sodium glucose co-transporter 2 (SGLT2) inhibitor.

Canagliflozin is indicated in adults aged 18 years and older with type 2 diabetes mellitus to improve glycemic control, as monotherapy when diet and exercise alone do not provide adequate glycemic control in patients for whom the use of metformin is considered inappropriate due to intolerance or contraindications, or as add-on therapy with other anti-hyperglycemic medicinal products including insulin, when these together with diet and exercise, do not provide adequate glycemic control.

The approval was based on a global Phase III clinical trial program, which enrolled 10,285 patients in nine studies, and is one of the largest late-stage development programs for an investigational pharmacological product for the treatment of type 2 diabetes submitted to health authorities to date, according to the sponsor.

Canagliflozin was first approved by the FDA in March 2013.