30 September 2019 - Approval is based on the landmark Phase 3 CREDENCE renal outcomes study - the only completed renal outcomes study of a diabetes medicine.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. FDA approved a new indication for Invokana (canagliflozin) to reduce the risk of end-stage kidney disease (ESKD), worsening of kidney function, cardiovascular death, and hospitalisation for heart failure in adults with type 2 diabetes and diabetic kidney disease (nephropathy) with a certain amount of protein in the urine.
Invokana is now the only type 2 diabetes medicine indicated to both treat diabetic kidney disease and reduce the risk of hospitalisation for heart failure in patients with type 2 diabetes mellitus an diabetic kidney disease.