Janssen seeks new indication for canagliflozin following CANVAS results

Janssen is seeking a new indication for its SGLT2 inhibitor canagliflozin stating that drug reduces the risk for major adverse cardiac events in adults with type 2 diabetes and established cardiovascular disease, the company announced in a press release.

The supplemental New Drug Application submitted to the FDA is based on data from the landmark CANVAS program, which found that patients with type 2 diabetes at high risk for CVD assigned canagliflozin (Invokana) 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 cardiac events, defined as a composite of death from CVD, nonfatal myocardial infarction 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).

The application also applies to canagliflozin’s fixed-dose combinations (Invokamet and Invokamet XR).

“People with type 2 diabetes have a substantially increased risk of developing cardiovascular disease, and it’s encouraging that we now have data to show Invokana may help address this challenge,” James F. List, MD, PhD, global therapeutic area head, cardiovascular and metabolism, Janssen, said in the release. “Invokana has shown a clear benefit in reducing cardiovascular risk in adults with type 2 diabetes, and we look forward to working with FDA as it reviews our filing.”