Expanded indications for patients with diabetic kidney disease
WASHINGTON -- In another label expansion, the FDA approved new cardiovascular and renal prevention indications for canagliflozin (Invokana), according to a statement from the Janssen unit of Johnson & Johnson.
The SGLT-2 inhibitor is now indicated for preventing end-stage kidney disease, worsening renal impairment, cardiovascular death, hospitalization for heart failure, and diabetic nephropathy with albuminuria in adults with type 2 diabetes and diabetic kidney disease.
A year ago, canagliflozin became the first SGLT-2 inhibitor to win a cardiovascular prevention indication, when the FDA approved it for reducing risk of major adverse cardiovascular events including myocardial infarction, stroke, and cardiovascular death. The oral drug was first approved in 2013 for improving glycemic control in type 2 diabetes.
Janssen said the new approval marks the first "in nearly 20 years" for a drug to reduce diabetic kidney disease progression in type 2 disease.
The approval comes in response to findings from the placebo-controlled CREDENCE study, which found canagliflozin led to 30% reduction in risk of a composite endpoint, comprising progression to end-stage kidney disease, doubling of serum creatinine, or renal or cardiovascular death in diabetic patients with chronic kidney disease. The study also showed a 34% reduction in renal endpoints alone with the drug.
Canagliflozin is not indicated for patients with type 1 diabetes, and carries a boxed warning label for increased risk of leg and foot amputation based on the CANVAS clinical program -- although CREDENCE found no increased risk for amputation.
In a statement, the National Kidney Foundation applauded "Janssen for bringing forth this new treatment and urges patients to discuss the implications of this new option with their healthcare professionals."
Read the full article on Medpage Today: Canagliflozin OK'd for Preventing HF Hospitalization in T2D