Canagliflozin sNDA Submitted for Chronic Kidney Disease with Diabetes

MARCH 28, 2019
Cecilia Pessoa Gingerich
FDA, A supplemental New Drug Application (sNDA) has been submitted to the US Food and Drug Administration (FDA) for canagliflozin (Invokana) for the indication to reduce the risk of end-stage kidney disease (ESKD) in adults with type 2 diabetes (T2D) and chronic kidney disease (CKD).

If approved, canagliflozin will be the first diabetes medication available for patients with type 2 diabetes and chronic kidney disease.

The application included data from the phase 3 CREDENCE (Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation) study of canagliflozin. Janssen Pharmaceutical Companies of Johnson & Johnson, which submitted the sNDA, announced that CREDENCE results will be presented at the International Society of Nephrology (ISN) World Congress of Nephrology (WCN) Annual Meeting in Melbourne, Australia on April 15, 2019.

"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, MD, PhD, Global Therapeutic Area Head, Cardiovascular & Metabolism, Janssen Research & Development, LLC, in a statement.

The CREDENCE trial was ended early in July 2018 due to achieving pre-specified criteria for efficacy. The study was a randomized, double-blind trial canagliflozin compared to placebo. It included 4401 patients with type 2 diabetes, stage 2 or 3 chronic kidney disease, and macroalbuminuria. Patients were receiving standard of care including a maximum tolerated daily dose of an angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blocker.

Currently, canagliflozin is contraindicated for patients with severe renal impairment (eGFR <30 mL/min/1.73 m2), end-stage renal disease, or patients requiring dialysis.

"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," added List.

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