BRIEF—CHMP backs label expansion for Invokana and Vokanamet

Janssen, the prescription medicines business of US healthcare giant  Johnson & Johnson, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion to update the Invokana (canagliflozin) and Vokanamet (canagliflozin and metformin) labels including changes to the indication statements.

The recommended product information now includes data on the reduction in major adverse cardiovascular events in patients with type 2 diabetes mellitus (T2DM) who had either a history of CV disease or at least two CV risk factors.

In welcoming the news as the UK exclusive distributor of the drugs, Napp Pharmaceuticals' medical director Paul Schofield said: “Improvements in glycemic control, the reduction of cardiovascular morbidity and mortality, as well as improvements in renal protection are important in the treatment of type 2 diabetes. As Janssen’s partner of choice in diabetes, we are pleased with the CHMP’s decision to recommend a label update for canagliflozin to include the positive findings from the CANVAS program. If approved by the European Commission, this will provide a more comprehensive overview of the effects of canagliflozin, and further assist clinicians in making informed treatment decisions that are most appropriate for their patients.”