FDA approves Invokana to treat diabetic kidney disease (DKD) and reduce the risk of hospitalization for heart failure in patients with type 2 diabetes and DK.- Janssen Pharma

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the FDA) 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 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 United States and the fifth fastest-growing cause of death around the world.

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 100 mg demonstrated a 30 percent 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 percent reduction in the risk of hospitalization for heart failure.

Overall, adverse events and serious adverse events were similar but numerically lower in the Invokana group compared to placebo. The rates of diabetic ketoacidosis and genital mycotic infections were numerically higher in the Invokana group, as observed in other clinical trials. Additionally, there was no imbalance in lower limb amputation or bone fracture in this trial and no new safety signals were identified.