FDA for INVOKANA® (canagliflozin) for the Treatment of Chronic Kidney Disease in Patients with Type 2 Diabetes
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking a new indication for INVOKANA® (canagliflozin) to reduce the risk of end-stage kidney disease (ESKD), the doubling of serum creatinine, which is a key predictor of ESKD, and renal or cardiovascular (CV) death in adults with type 2 diabetes (T2D) and chronic kidney disease (CKD). The submission is based on results from the Phase 3 CREDENCE (Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation) study, which evaluated the efficacy and safety of INVOKANA® versus placebo in this high-risk patient population when used in addition to standard of care.
Primary investigators will present the CREDENCE data during a late-breaking clinical trials session at the International Society of Nephrology (ISN) World Congress of Nephrology (WCN) Annual Meeting in Melbourne, Australia on April 15 at 8:30 am AEST (April 14 at 6:30 pm EDT in the U.S.). An open access live-stream of the late-breaking presentation can be accessed here (registration is required).
“Today, millions of people living with type 2 diabetes and chronic kidney disease are at high risk of experiencing kidney failure, and unfortunately, we have not seen treatment innovation for these patients in almost 20 years. Janssen’s application is a significant step toward bringing a much-needed, new standard of care for those living with these serious conditions,” said James List, M.D., Ph.D., Global Therapeutic Area Head, Cardiovascular & Metabolism, Janssen Research & Development, LLC. “We look forward to presenting the CREDENCE data at the ISN World Congress of Nephrology and working closely with the FDA to bring this important medicine as quickly as possible to people living with type 2 diabetes and chronic kidney disease.” … read more