The FDA approved canagliflozin Sept. 30 to reduce the risk of end-stage kidney disease, worsening kidney function, CV death and hospitalization for heart failure in adults with type 2 diabetes and diabetic nephropathy (DKD).
The agency’s expanded indication means canagliflozin, manufactured as Invokana by Janssen Pharmaceutical Companies of Johnson & Johnson, is now the only diabetes medication approved to help type 2 diabetics reduce the risks associated with diabetic kidney disease. One in three people in the U.S. with type 2 diabetes also has DKD, and nephropathy only compounds the risk of CV complications like heart failure and death.
It also leaves patients on a fast-track to dialysis or kidney transplant.
“Given the nation’s heightened focus on kidney health at the highest levels of government, this approval couldn’t have come at a better time and offers real hope for patients with type 2 diabetes and diabetic kidney disease,” LaVarne A. Burton, president and CEO of the American Kidney Fund, said in a statement. “We know that the real battle to turn the tide on kidney disease is in early detection and slowing its progression so that patients stay healthier and fewer patients reach kidney failure.”
The new indication is based on the results of the Phase 3 CREDENCE trial, which studied the effect of canagliflozin in treating people with both type 2 diabetes and DKD. The trial, which found a 30% reduction in the risk of end-stage kidney disease, doubled serum creatinine or renal or CV death with 100 milligrams of Invokana, was halted early because it met prespecified criteria for efficacy.
“Millions of T2D patients around the world have DKD and almost half of them aren’t even aware of it,” CREDENCE investigator George Bakris, MD, said in a release. “By the time they are referred to a nephrologist, it is often too late because their disease has progressed to the point where dialysis is inevitable.
“With the approval for this new indication for Invokana, physicians will not only be able to help reduce the risks associated with diabetic kidney disease, but also reduce the risk of hospitalization for heart failure in patients with T2D and DKD.”
After graduating from Indiana University-Bloomington with a bachelor’s in journalism, Anicka joined TriMed’s Chicago team in 2017 covering cardiology. Close to her heart is long-form journalism, Pilot G-2 pens, dark chocolate and her dog Harper Lee.