Posted by Michael Wonder on 06 Aug 2018
Janssen receives positive CHMP opinion to expand Invokana and Vokanamet labelling to include positive data on cardiovascular morbidity and mortality
2 August 2018 - Update based on positive cardiovascular outcomes from CANVAS Program.
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the CHMP, of the EMA, has issued a positive opinion to update the Invokana (canagliflozin) and Vokanamet (canagliflozin and metformin) labelling including changes to the indication statement for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise.
The recommended 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 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.
