Janssen Files With FDA for CV Indication for Canagliflozin

The filing also seeks new indications for fixed-dose combinations of canagliflozin and metformin.

Janssen Research & Development has filed with the FDA to add a cardiovascular (CV) indication to canagliflozin, its popular therapy for type 2 diabetes (T2D) sold as Invokana. Company officials announced the supplemental new drug application in a statement today.

In the application, Janssen also seeks CV indications for canagliflozin fixed-dose combinations Invokamet and Invokamet XR, the statement said.

The filing was anticipated after a presentation in June at the 77th Scientific Sessions of the American Diabetes Association in San Diego, California, where results of the CANVAS and CANVAS-R studies showed a 14% reduction in the combined primary endpoint of nonfatal heart attacks, nonfatal strokes, and CV death. Results simultaneously published in the New England Journal of Medicine also found that patients taking canagliflozin had a lower risk of hospitalization for heart failure, less loss of kidney function, and a lower risk of progression to albuminuria.

“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 company’s statement. “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.”

Canagliflozin was the first sodium glucose co-transporter-2 (SGLT2) inhibitor approved to treat T2D in March 2013. FDA previously approved a CV indication for empagliflozin, an SGLT2 inhibitor sold as Jardiance by Eli Lilly and Boehringer-Ingelheim. SGLT2 inhibitors have a mechanism of action that involves blocking a protein that normally allows the body to reabsorb glucose; instead, the body discharges excess glucose through the urine, offering people with T2D glycemic control, as well as reduced blood pressure and modest weight loss.

Another agent approved to treat T2D, the glucagon-like peptide-1 receptor agonist liraglutide, sold by Novo Nordisk as Victoza, recently received a CV indication based on results that found it reduced the risk of CV death by 22%.