Janssen Aims for Supplemental U.S. FDA Approval for INVOKANA®

The company has submitted an sNDA for INVOKANA® as a treatment for adults with type 2 diabetes and chronic kidney disease.

 

People suffering from type 2 diabetes and chronic kidney disease are often at high risk for experiencing kidney failure. As yet, no treatments have been developed to reduce this risk for these patients, according to James List, M.D., Ph.D., Global Therapeutic Area Head, Cardiovascular & Metabolism, Janssen Research & Development, LLC, who is working to address the lack of treatment.

 

Recently, Janssen Pharmaceutical Companies of Johnson & Johnson submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for its drug INVOKANA® (canagliflozin) as a treatment for reducing the risk of end-stage kidney disease (ESKD), the doubling of serum creatinine (a key predictor of ESKD), and renal or cardiovascular (CV) death in adults with type 2 diabetes (T2D) and chronic kidney disease (CKD).

 

Positive results from the phase III Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) randomized, double-blind, event-driven, placebo-controlled, parallel-group, two-arm, multicenter study served as the basis for the submission. The trial, which involved over 4400 patients with T2D, stage 2 or 3 CKD and macroalbuminuria who were receiving standard of care including a maximum tolerated labeled daily dose of an angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB), was halted early in July 2018 because it had already met the pre-specified criteria for efficacy.

 

INVOKANA® is a sodium glucose co-transporter 2 (SGLT2) inhibitor. If approved, it will be the first diabetes drug for the treatment of patients with both T2D and CKD.

Cynthia A. Challener, Ph.D.

Dr. Challener is an established industry editor and technical writing expert in the areas of chemistry and pharmaceuticals. She writes for various corporations and associations, as well as marketing agencies and research organizations, including That’s Nice and Nice Insight.