The FDA has approved canagliflozin (Invokana®; Janssen Pharmaceuticals) for reducing the risk of diabetic nephropathy progression and hospitalization for heart failure in patients with type 2 diabetes (T2D) and diabetic kidney disease (DKD). Canagliflozin is the first new treatment option in nearly 20 years indicated to slow DKD progression in these patients.
The decision stemmed from the landmark phase 3 CREDENCE (Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation) trial that found canagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, added to standard of care (including maximally dosed angiotensin-converting enzyme [ACE] inhibitors and angiotensin II receptor blockers [ARBs]) reduced the risks for kidney failure and cardiovascular events.
“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 [type 2 diabetes] and DKD,” CREDENCE investigator George Bakris, MD, of the University of Chicago, stated in a company press release.
“This significant advancement addresses serious unmet needs and could change the trajectory of care for the many millions of patients living with type 2 diabetes and diabetic kidney disease,” James List, MD, PhD, of Janssen Research & Development, LLC added.
In a statement, the New York-based National Kidney Foundation lauded the approval and urged patients and healthcare professionals to discuss the pros and cons of the new option.
US FDA approves Invokana® (canagliflozin) to treat diabetic kidney disease (DKD) and reduce the risk of hospitalization for heart failure in patients with type 2 diabetes (T2D) and DKD. Sept. 30, 2019. [Janssen Pharmaceuticals news release].
FDA approves new drug to treat diabetes-related kidney disease. New York, NY. Sept. 30, 2019. [National Kidney Foundation news release]