The US Food and Drug Administration (FDA) has approved a new indication for Janssen’s Invokana (canagliflozin).
The treatment has been approved to reduce the risk of hospitalisation for heart failure in certain patients with type II diabetes and to slow the progression of diabetic nephropathy.
The approval means that Invokana is now the only type II diabetes medicine indicated to both treat diabetic kidney disease and reduce the risk of hospitalisation for heart failure in patients with type II diabetes and diabetic nephropathy.
The indication is based on results from the Phase III CREDENCE study, which was stopped early because it met the pre specified criteria for efficacy. In CREDENCE, 100 mg of the drug 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.
The results also showed that it reduced the risk of secondary CV endpoints, including a 39% reduction in the risk of hospitalisation for heart failure.
“With the approval of these new uses, Invokana is now the only diabetes medicine indicated to help type II diabetes patients reduce the risks associated with diabetic kidney disease, including hospitalisation for heart failure,” said James List, global therapeutic area head, cardiovascular & metabolism, Janssen Research & Development.
He continued, “This significant advancement addresses serious unmet needs and could change the trajectory of care for the many millions of patients living with type II diabetes and diabetic kidney disease.”
Type II diabetes is the leading cause of kidney disease in the United States and the fifth fastest-growing cause of death around the world.