Canagliflozin Approved for Renal Disease, Cardiovascular Events in T2D

SEPTEMBER 30, 2019
Kevin Kunzmann
FDAThe US Food and Drug Administration (FDA) has approved canagliflozin (INVOKANA) for the reduction of end-stage kidney disease and cardiovascular events in patients with both type 2 diabetes and chronic kidney disease (CKD).

With the approval, canagliflozin becomes the first drug indicated for diabetic kidney disease in almost 2 decades.

The approval, granted to Janssen Pharmaceutical, was based on the results of the landmark phase 3 CREDENCE trial. The study results, published in April of this year, showed the oral therapy was associated with a 30% reduction in risk to progression of end-stage kidney disease, doubling of serum creatinine, and renal or cardiovascular death among patients with CKD and type 2 diabetes, compared to placebo.

The double-blind study, which included 4401 patients, showed the drug—along with standard care—was associated with a 32% reduction in end-stage kidney disease alone (HR, 0.68; (95% CI, 0.54 – 0.86; P = .0015). Canagliflozin also reduced risk of cardiovascular death and hospitalization for heart failure by 31% (HR, 0.69; 95% CI, 0.57 – 0.83; P = .0001) and major cardiovascular events (MACE) by 20% (HR, 0.80; 95% CI, 0.67 – 0.95; P = .0121).

Additionally, there were fewer reported adverse events and serious adverse events among the treatment arm, with no statistically significant difference in incidence of amputations or adjudicated fractures.

According to the National Kidney Foundation, diabetes accounts for 44% of all end-stage renal disease cases—though just less than 40% of all patients with diabetes are completely assessed for kidney disease. The foundation praised the effort from Janssen to help bring a therapy beneficial across the comorbid patient population to the market.

"Diabetes and CKD are common and complex disorders, which often co-exist, and each are associated with multiple comorbid conditions and higher risk for mortality,” the foundation wrote in a statement. “INVOKANA, a SGLT2 inhibitor that has been used for glycemic control in people with diabetes by inhibiting renal reabsorption of glucose, has now been shown to reduce the risk of kidney failure and heart disease in this population.”

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