U.S. FDA Grants Priority Review of INVOKANA® (canagliflozin) sNDA for the Treatment of Chronic Kidney Disease in Patients with Type 2 Diabetes
"Millions of people with type 2 diabetes will develop chronic kidney disease,i,ii which leads to a high risk of progressing to kidney failure and developing CV disease.iii 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, LLC. "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. https://www.nasdaq.com/press-release/us-fda-grants-priority-review-of-invokana-canagliflozin-snda-for-the-treatment-of-chronic-kidney-20190522-00555
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