Posted by Michael Wonder on 10 Sep 2018
European Commission expands labelling for Janssen’s Invokana and Vokanamet to include positive data on cardiovascular outcomes
7 September 2018 - Invokana (canagliflozin) and Vokanamet (canagliflozin and metformin) labelling now approved to include positive cardiovascular outcomes from the CANVAS Program which show a reduction in morbidity and mortality.
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the European Commissionhas 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.
