Janssen announced the submission of a supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) for Invokana (canagliflozin) to reduce the risk of end-stage renal disease and renal or cardiovascular (CV) death in adults with type 2 diabetes and chronic kidney disease. If approved, it will be the first therapy to treat patients with both chronic kidney disease and type 2 diabetes.
The sNDA was supported by data from the phase 3 multicenter, randomized, double-blind, event-driven, placebo-controlled, parallel-group, 2-arm CREDENCE (Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation) study (N=4401) that compared canagliflozin vs placebo when used in addition to standard of care. Enrolled patients had type 2 diabetes, stage 2 or 3 chronic kidney disease (eGFR ≥30 to <90mL/min/ 1.73m2), and macroalbuminuria, who were receiving standard of care including a maximum tolerated daily dose of an ACE inhibitor or ARB.
The study was stopped early (July 2018) because it met the pre-specified criteria for efficacy, based on an Independent Data Monitoring Committee meeting. Full findings from CREDENCE will be presented at the upcoming International Society of Nephrology (ISN) World Congress of Nephrology (WCN) Annual Meeting in Melbourne, Australia.
Invokana, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, is currently approved as adjunct to diet and exercise to lower glucose in adults with type 2 diabetes, and to reduce the risk of major cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes who have known cardiovascular disease. It is available as 100mg and 300mg tablets.
For more information visit Janssen.com.