The U.S. Food and Drug Administration (FDA) has approved the sodium-glucose cotransporter type 2 (SGLT2) inhibitor Invokana^® (canagliflozin) to reduce the risk of major adverse cardiovascular (CV) events, including heart attack, stroke or death due to a CV cause in adults with type 2 diabetes (T2D) who have established CV disease. Invokana^® thus becomes the first and only oral diabetes drug 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 with (65 percent) or at risk for CVD (35 percent). Overall, treatment with Invokana^® (as compared with placebo) plus standard of care reduced the combined risk of heart attack, stroke and CV death by 14% (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 Invokana^® reduced the combined risk of heart attack, stroke and CV death by 18% 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).

Approval aligns with ADA and AACE treatment guidance and supports the use of Invokana^® across a broad range of patients. This new indication also applies to the fixed-dose combinations of Invokamet^® (canagliflozin/metformin HCl) tablets and Invokamet^® XR (canagliflozin/metformin HCl extended-release) tablets.

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