Johnson & Johnson’s Janssen has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for a new indication for Invokana (canagliflozin).
The indication is to reduce the risk of end-stage kidney disease (ESKD), the doubling of serum creatinine, which is a key predictor of ESKD, and renal or cardiovascular (CV) death in adults with type II diabetes and chronic kidney disease (CKD).
The submission is based on results from the Phase III CREDENCE study, which stopped early due to positive efficacy findings.
“Today, millions of people living with type II 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, global therapeutic area head, cardiovascular & metabolism, Janssen Research & Development, LLC.
He continued, “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.”
The study consisted of 4,401 patients with type II diabetes, stage two or three CKD, and and macroalbuminuria who were already receiving the standard of care.
If the sNDA is approved, the drug will be the first and only therapy in nearly 20 years indicated to reduce the risk of end-stage kidney disease when added to current standard of care.