FDA green light for Invokana in diabetic kidney disease

The US Food and Drug Administration has approved a new indication for Invokana (canagliflozin) to reduce the risk of end-stage kidney disease (ESKD), worsening of kidney function, cardiovascular (CV) death, and hospitalization for heart failure in adults with type 2 diabetes and diabetic kidney disease (nephropathy) with a certain amount of protein in the urine.

Invokana, from US healthcare giant Johnson & Johnson (NYSE: JNJ) subsidiary Janssen, is now the only type 2 diabetes medicine indicated to both treat diabetic kidney disease and reduce the risk of hospitalization for heart failure in patients with T2D and DKD. T2D is the leading cause of kidney disease in the USA and the fifth fastest-growing cause of death around the world.

"With the approval of these new uses, Invokana is now the only diabetes medicine indicated to help type 2 diabetes patients reduce the risks associated with diabetic kidney disease, including hospitalization for heart failure," said Dr James List, global therapeutic area head, Cardiovascular & Metabolism, Janssen Research & Development, adding: "This significant advancement addresses serious unmet needs and could change the trajectory of care for the many millions of patients living with type 2 diabetes and diabetic kidney disease."

Clinical backing

The new indication is based on results from the landmark Phase III  CREDENCE study in patients with T2D and DKD, which was stopped early because it met the prespecified criteria for efficacy. In CREDENCE, Invokana 100mg demonstrated a 30% reduction in the risk of the primary composite endpoint, comprising end-stage kidney disease (ESKD), doubling of serum creatinine and renal or CV death. Results also showed Invokana reduced the risk of secondary CV endpoints, including a 39% reduction in the risk of hospitalization for heart failure.