FDA approves canagliflozin to treat diabetic kidney disease in type 2 diabetes patients
The drug regulatory body, U.S. Food and Drug Administration (FDA), has approved a new indication for canagliflozin and that is to reduce 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) who have a certain amount of protein in their urine.
Read also: Add on semaglutide leads to better blood sugar control compared to canagliflozin in diabetes: Lancet
"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 James List, M.D., Ph.D., Global Therapeutic Area Head, Cardiovascular & Metabolism, Janssen Research & Development, LLC. "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."
The new indication is based on results from the landmark Phase 3 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.
Read also: GLP-1 receptor agonist Dulaglutide cuts cardiovascular and kidney risk in diabetics, finds international study
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.
INVOKANA is a prescription medicine used:
- along with diet and exercise to lower blood sugar (glucose) in adults with type 2 diabetes
- to reduce the risk of major cardiovascular events such as heart attack, stroke, or death in adults with type 2 diabetes who have known cardiovascular disease
- to reduce the risk of end-stage kidney disease (ESKD), worsening of kidney function, cardiovascular death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic kidney disease (nephropathy) with a certain amount of protein in the urine
INVOKANA is not for people with type 1 diabetes or with diabetic ketoacidosis (increased ketones in blood or urine). It is not known if INVOKANA is safe and effective in children under 18 years of age.
Read also: Kidney Functions decline more rapidly in diagnosed Diabetics