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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.

Diabetes is the leading cause of kidney failure, accounting for 44% percent of new cases.

Kidney specialists and scientists have been searching for an intervention to slow kidney disease progression. Canagliflozin may help reduce the risks associated with diabetic kidney disease but may also reduce the risk of hospitalization for heart failure in people with type 2 diabetes.

According to the National Kidney Foundation, 10% of the population worldwide is affected by CKD, and millions die each year because they do not have access to affordable treatment.  Over 2 million people worldwide, primarily in wealthy countries like the USA, currently receive treatment with dialysis or a kidney transplant to stay alive, yet this number only represents 10% of people who require treatment to live.

Almost half of the people living with kidney disease are not aware they have it.  There is an increased risk for kidney disease if a person has:

  • diabetes
  • high blood pressure
  • a family history of kidney failure

or

  • is older
  • belongs to a population group that has a high rate of diabetes or high blood pressure, including African, Hispanic, Asian, Pacific Islanders, or indigenous people.

Canagliflozin is not for people with type 1 diabetes or with diabetic ketoacidosis (increased ketones in blood or urine). It is not known if canagliflozin is safe and effective in children under 18 years of age.


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