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Diabetes Drug ‘Home Run’ Curtailing Kidney Failure Risk

MELBOURNE, Australia — Canagliflozin (Invokana, Janssen) lowers the risk for progression to end-stage kidney disease by 30% in patients with type 2 diabetes and chronic kidney disease, according to first results from a global phase 3 trial that investigators called “landmark”.

The multicenter, randomized, double-blind, placebo-controlled CREDENCE trial (NCT02065791) of 4401 patients also showed that canagliflozin significantly lowers risks for major cardiovascular events, including death and hospitalization for heart failure.

“This is something that will be truly beneficial for our patients,” said Vlado Perkovic, MBBS, PhD, from the George Institute for Global Health and the University of New South Wales in Sydney, Australia.

“Many still end up progressing, having cardiovascular events, or dying from complications of kidney failure, but we now have a proven treatment to help patients with diabetes and kidney disease lead perhaps an even longer life,” Perkovic told Medscape Medical News. “This is the home run we were hoping for but not banking on.”

Perkovic and his colleagues presented the findings in front of an audience of about 800 during a late-breaking clinical trials session here at the International Society of Nephrology (ISN): 2019 World Congress. The study was published online in the New England Journal of Medicine to coincide with its presentation, along with an accompanying editorial.

Canagliflozin is the first new therapy in nearly 20 years to reduce the risk for kidney failure when added to the current standard of care in patients with chronic kidney disease and type 2 diabetes, the leading cause of end-stage kidney disease around the world. The last therapies approved for this indication were ACE inhibitors and angiotensin-receptor blockers, which are now considered the standard of care in this patient population.

Janssen hinted at the strength of the CREDENCE trial results 2 weeks ago by announcing that it has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for the treatment of patients with chronic kidney disease and type 2 diabetes.

Fast-Tracking Through Regulatory Review

The sNDA has been submitted for priority review, which, if successful, would be approved in 6 months, said Norman Rosenthal, MD, vice president and clinical and compound development leader in metabolism for Janssen.

The drug, a sodium-glucose cotransporter-2 (SGLT2) inhibitor, was approved for the treatment of type 2 diabetes by the FDA and the European Medicines Agency in 2013. That indication was expanded in 2018 to include patients with established cardiovascular disease, a population in which canagliflozin can lower the risk for heart attack, stroke, and death.

The CREDENCE trial, launched in 2014, was stopped nearly a year earlier than planned because it met its prespecified efficacy end points, as previously reported by Medscape Medical News.

“This is a game-changer, a whole new strategy we can use,” said study coauthor Meg Jardine, MBBS, PhD, also from the George Institute for Global Health.

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