European Commission extends Invokana label to include data from CANVAS study of CV risk in diabetic patients.- Janssen.

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the European Commission (EC) has granted approval to update the Invokana (canagliflozin) and Vokanamet (canagliflozin and metformin) labelling to include changes to the indication statement for the treatment of adults with insufficiently controlled type 2 diabetes mellitus (T2DM) as an adjunct to diet and exercise.

The decision means that the product information now includes data on the reduction in major adverse cardiovascular (CV) events (cardiovascular mortality, non-fatal myocardial infarction, or non-fatal stroke) in patients with type 2 diabetes mellitus (T2DM) who had either a history of CV disease or at least two CV risk factors, in addition to the existing study results on improving glycemic control.

The EC�s decision follows a recommendation from the Committee for Medical Products for Human Use (CHMP) that was based on data from the CANVAS Program, the largest completed CV outcomes trial to date for an SGLT2 inhibitor. The study, which included over 10,000 patients started in 2009, met its primary endpoint and showed canagliflozin significantly reduced the combined risk of CV death, myocardial infarction and non-fatal stroke, versus placebo in adult patients with T2DM who had either a history of CV disease or at least two CV risk factors. Canagliflozin also significantly lowered the risk of hospitalisation for heart failure and demonstrated improved renal outcomes.