New Indication Granted for Invokana
October 30, 2018 – The U.S. FDA has approved a new indication for Invokana® (canagliflozin), manufactured by Janssen Pharmaceutical, to reduce the risk of major adverse cardiovascular (CV) events in adults who have type 2 diabetes mellitus and established cardiovascular disease. Patients diagnosed with type 2 diabetes are up to three times more likely to die due to cardiovascular disease than those who are not.
In a clinical study, patients treated with Invokana experienced a 14% reduction in their combined risk of heart attack, stroke, and CV death compared to patients who received a placebo. Study participants had type 2 diabetes and either established cardiovascular disease or two or more risk factors for cardiovascular disease. For patients who had established cardiovascular disease, their combined risk of heart attack, stroke, and CV death went down by 18% compared to patients on placebo.
The new indication also applies to the fixed-dose combinations of Invokamet® (canagliflozin/metformin HCl) tablets and Invokamet® XR (canagliflozin/metformin HCl extended-release) tablets.