The US Food and Drug Administration (FDA) approved canagliflozin (Invokana, Janssen) to reduce the risk of end-stage kidney disease, worsening of kidney function, cardiovascular death, and hospitalization for heart failure in adults with type 2 diabetes and chronic kidney disease (CKD).
The European Medicines Agency (EMA) accepted the licence extension submission (August 23, 2019) for canagliflozin to treat stage two or stage three CKD and albuminuria as an adjunct to standard of care in adults with type 2 diabetes.
Canagliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, is one of a relatively new class of drugs recommended for persons with type 2 diabetes. SGLT2 inhibitors work by preventing glucose from being absorbed in the kidneys. As a result, they decrease glucose in the blood and cause it to spill into the urine.
Diabetes is the leading cause of kidney failure, accounting for 44% percent of new cases. Kidney disease is more common in people with diabetes than in people without diabetes. It is caused by damage to small blood vessels, which results in decreased kidney function or failure altogether. Heart disease is the major cause of death for all people with CKD.
The new indication is based on results from the landmark Phase 3 CREDENCE study in people with type 2 diabetes and CKD. In CREDENCE, canagliflozin demonstrated a 30 percent reduction in the risk of the primary composite endpoint, comprising end-stage kidney disease, doubling of serum creatinine and renal or cardiovascular death. Results also showed a reduced risk of secondary cardiovascular endpoints, including a 39 percent reduction in the risk of hospitalization for heart failure.