Janssen announced that the Food and Drug Administration (FDA) has approved Invokana (canagliflozin) to reduce the risk of major cardiovascular (CV) events, including myocardial infarction (MI), stroke or death due to a CV cause in adults with type 2 diabetes (T2D) who have established CV disease. The update also applies to the Invokamet (canagliflozin, metformin HCl) and Invokamet XR (canagliflozin, metformin HCl ext-rel) labels however, the effectiveness of Invokamet and Invokamet XR on reducing the risk of major cardiovascular events in adults with type 2 diabetes and cardiovascular disease has not been established.
The effect of Invokana on CV risk was evaluated in the CANVAS (CANagliflozin cardioVascular Assessment Study) Program in >10,000 adults with T2D who had established CV disease or were at risk for CV disease with ≥2 risk factors. The primary endpoint of the study was major adverse CV events (MACE), composed of nonfatal MI, nonfatal stroke and CV death.
Results showed that compared with placebo, treatment with Invokana (plus standard of care) lowered the risk of MACE by 14% overall (events occurred in 26.9 vs 31.5 patients per 1000 patient-years; hazard ratio [HR] 0.86, 95% CI, 0.75, 0.97; P <.0001 for non-inferiority and P =.0158 for superiority). With regard to patients with established CV disease, treatment with Invokana reduced the risk of MACE by 18% vs placebo (events occurred in 34.1 vs 41.3 participants per 1000 patient-years; HR 0.82; 95% CI, 0.72 to 0.95).
“This FDA approval makes Invokana the only oral type 2 diabetes treatment indicated to reduce the risk of heart attack, stroke or CV death,” said James List, MD, PhD, Global Therapeutic Area Head, Cardiovascular & Metabolism, Janssen Research & Development, LLC. “It is an important step forward for patients and the physicians who treat them.”
Invokana, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, was initially approved in March 2013 as an adjunct to diet and exercise to improve glycemic control in adults with T2D. It is supplied in 100mg and 300mg strength tablets in 30-, 90-, 500-count bottles and 10×10 blister cards.
For more information call (800) 526-7736 or visit Invokana.com.