Posted by Michael Wonder on 29 Mar 2019
Janssen submits supplemental new drug application to U.S. FDA for Invokana (canagliflozin) for the treatment of chronic kidney disease in patients with type 2 diabetes mellitus
28 March 2019 - Submission is based on data from the landmark Phase 3 CREDENCE renal outcomes study, which stopped early for positive efficacy findings.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a supplemental new drug application to the U.S. FDA seeking a new indication for Invokana (canagliflozin) to reduce the risk of end-stage kidney disease (ESRD), the doubling of serum creatinine, which is a key predictor of ESKD, and renal or cardiovascular death in adults with type 2 diabetes mellitus and chronic kidney disease.
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.
