Janssen Pharmaceutical, a Johnson and Johnson company, announced the U.S. Food and Drug Administration (FDA) has granted priority review for the supplemental New Drug Application (sNDA) for INVOKANA® (canagliflozin).
If approved for this new indication, INVOKANA® will be the first and only diabetes medicine to treat chronic kidney disease in patients with T2D.
According to Dr. James List, global therapeutic area head, cardiovascular & metabolism, at Janssen Research & Development, 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,” he said in a statement. “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 application was submitted in March 2019 based on landmark phase 3 CREDENCE renal outcomes study published in the New England Journal of Medicine.
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® is also indicated to lower blood sugar in adults with T2D.
- The Janssen Pharmaceutical Companies. U.S. FDA Grants Priority Review of INVOKANA® (canagliflozin) sNDA for the Treatment of Chronic Kidney Disease in Patients with Type 2 Diabetes. (2019, May 22) Retrieved: https://www.prnewswire.com/news-releases/us-fda-grants-priority-review-of-invokana-canagliflozin-snda-for-the-treatment-of-chronic-kidney-disease-in-patients-with-type-2-diabetes-300855112.html