The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for Invokana (canagliflozin; Janssen) to reduce the risk of end-stage renal disease (ESRD) and renal or cardiovascular (CV) death in adults with type 2 diabetes (T2D) and chronic kidney disease (CKD).
The sNDA was supported by data from the phase 3, event-driven, placebo-controlled, parallel-group, 2-arm CREDENCE (Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation) trial (N=4401). The study enrolled patients with T2D, stage 2 or 3 CKD (eGFR ≥30 to <90mL/min/ 1.73m2), and macroalbuminuria, who were receiving standard of care including a maximum tolerated daily dose of an angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB); patients were randomized to receive canagliflozin 100mg daily or placebo.
Results showed that after a median follow-up duration of 2.62 years, canagliflozin-treated patients had a statistically significant 30% lower risk of the primary composite outcome of ESRD, doubling of serum creatinine level, or death from renal or CV causes compared with those who received placebo. In addition, the study authors reported that “the relative risk of the renal-specific composite of end-stage kidney disease, a doubling of the creatinine level, or death from renal causes was lower by 34% (hazard ratio, 0.66; 95% CI, 0.53 to 0.81; P <.001), and the relative risk of end-stage kidney disease was lower by 32% (hazard ratio, 0.68; 95% CI, 0.54 to 0.86; P =.002).”
The Priority Review designation shortens the review period for the sNDA from 10 months to 6 months. “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, MD, PhD, Global Therapeutic Area Head, Cardiovascular & Metabolism, Janssen Research & Development, LLC.
Invokana, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, is currently approved as an adjunct to diet and exercise to improve glycemic control in adults with T2D, as well as to reduce the risk of major CV events (eg, CV death, nonfatal MI and stroke) in adults with T2D and established CV disease.
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