FDA approves Invokana to reduce the risk of major adverse cardiovascular (CV) events. - Janssen Pharma

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the FDA has approved Invokana (canagliflozin) to reduce the risk of major adverse cardiovascular (CV) events, including heart attack, stroke or death due to a cardiovascular cause in adults with type 2 diabetes (T2D) who have established CV disease. Invokana is the first and only oral diabetes treatment approved with this indication.

The CANVAS (CANagliflozin cardioVascular Assessment Study) Program evaluated the effect of Invokana on CV risk in a broad population of more than 10,000 adults with T2D who had established CV disease (65 percent) or were at risk for cardiovascular disease with two or more risk factors (35 percent). Overall, treatment with Invokana as compared with placebo in addition to standard of care reduced the combined risk of heart attack, stroke and CV death by 14 percent (events occurred in 26.9 vs. 31.5 participants, respectively, per 1000 patient-years; HR: 0.86; 95 percent CI: 0.75 to 0.97; p<0.0001 for non-inferiority and p="0.0158" for superiority. in patients with established cv disease treatment with invoaka reduced the combined risk of heart attack stroke and cv death by 18 percent compared to placebo events occurred in 34.1 vs. 41.3 participants respectively per 1000 patient-years hr: 0.82 95 percent ci: 0.72 to 0.95.>