FDA News

FDA approves CV events indication for Invokana

The FDA has approved an expanded indication for the SGLT2 inhibitor canagliflozin to include language in the prescribing information that the drug can reduce risk for major adverse cardiovascular events, including myocardial infarction, stroke or CV death, in adults with type 2 diabetes and established CVD, according to a press release from Janssen Pharmaceuticals.

This decision makes canagliflozin (Invokana, Janssen) the third diabetes drug to receive a CV indication — and the first oral to receive a specific major adverse CV events indication. The GLP-1 receptor agonist liraglutide (Victoza, Novo Nordisk) also has a major adverse CV events indication, and the SGLT2 inhibitor empagliflozin (Jardiance, Boehringer Ingelheim and Lilly) is indicated to reduce the risk for CV death in this patient population.

The decision is based on results from the landmark CANVAS program, which found that patients with type 2 diabetes at high risk for CVD assigned canagliflozin saw a 33% reduction in risk for hospitalization for heart failure and were 40% less likely to experience renal decline vs. those assigned placebo. Researchers found that the rate of major adverse CV events, defined as a composite of death from CVD, nonfatal MI and nonfatal stroke, was lower in participants assigned canagliflozin vs. placebo, occurring in 26.9 per 1,000 patient-years vs. 31.5 per 1,000 patient-years (HR = 0.86; 95% CI, 0.75-0.97; P for noninferiority < .0001; P for superiority = .0158).

The FDA has approved an expanded indication for the SGLT2 inhibitor canagliflozin to include language in the prescribing information that the drug can reduce risk for major adverse cardiovascular events, including myocardial infarction, stroke or CV death, in adults with type 2 diabetes and established CVD, according to a press release from Janssen Pharmaceuticals.

This decision makes canagliflozin (Invokana, Janssen) the third diabetes drug to receive a CV indication — and the first oral to receive a specific major adverse CV events indication. The GLP-1 receptor agonist liraglutide (Victoza, Novo Nordisk) also has a major adverse CV events indication, and the SGLT2 inhibitor empagliflozin (Jardiance, Boehringer Ingelheim and Lilly) is indicated to reduce the risk for CV death in this patient population.

The decision is based on results from the landmark CANVAS program, which found that patients with type 2 diabetes at high risk for CVD assigned canagliflozin saw a 33% reduction in risk for hospitalization for heart failure and were 40% less likely to experience renal decline vs. those assigned placebo. Researchers found that the rate of major adverse CV events, defined as a composite of death from CVD, nonfatal MI and nonfatal stroke, was lower in participants assigned canagliflozin vs. placebo, occurring in 26.9 per 1,000 patient-years vs. 31.5 per 1,000 patient-years (HR = 0.86; 95% CI, 0.75-0.97; P for noninferiority < .0001; P for superiority = .0158).