FDA Grants Priority Review of INVOKANA® sNDA for Chronic Kidney Disease in Patients with Type 2 Diabetes

Janssen announced the U.S. Food and Drug Administration (FDA) has granted Priority Review for the supplemental New Drug Application (sNDA) for INVOKANA® (canagliflozin) to reduce the risk of end-stage kidney disease (ESKD), the doubling of serum creatinine, and renal or cardiovascular (CV) death in adults with type 2 diabetes (T2D) and chronic kidney disease (CKD). If approved for this new indication, INVOKANA® will be the first and only diabetes medicine to treat CKD in patients with T2D.

"Millions of people with type 2 diabetes will develop chronic kidney disease, which leads to a high risk of progressing to kidney failure and developing CV disease.  We are pleased the FDA recognizes the urgency to deliver a novel treatment that can reduce the risk of kidney failure and prevent life-threatening cardiovascular events in people with type 2 diabetes and chronic kidney disease," said James List, M.D., Ph.D., Global Therapeutic Area Head, Cardiovascular & Metabolism, Janssen Research & Development. "This Priority Review designation brings us one step closer to addressing this major unmet need and providing a new standard of care to those living with this serious condition."

The FDA grants Priority Review to medicines that may offer significant improvements in the treatment, diagnosis or prevention of a serious condition. This designation shortens the review period to six months compared to 10 months for Standard Review.

The FDA most recently approved a new indication for INVOKANA® in October 2018 to reduce the risk of major adverse CV events, including heart attack, stroke or death due to a cardiovascular cause in adults with T2D who have established CV disease. INVOKANA® is also indicated to lower blood sugar in adults with T2D.

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