The SGLT-2 inhibitor canagliflozin was FDA-approved on September 30, 2019, to slow progression of diabetic kidney disease and reduce risk of heart failure hospitalization.
The FDA on September 30, 2019, approved a label expansion for canagliflozin (INVOKANA, Janssen Pharmaceuticals Companies) to reduce the risk of end-stage renal disease (ESRD), worsening of kidney function, cardiovascular (CV) death, and hospitalization for heart failure (HF) in adults with type 2 diabetes (T2D) and nephropathy with albuminuria.
With this approval, canagliflozin becomes the only medication for T2D indicated to reduce the risk of hospitalization for heart failure in patients with T2D and diabetic nephropathy and is the first new treatment in nearly 20 years approved to slow the progression of kidney disease in these patients.
"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," said James List, MD, PhD, Global Therapeutic Area Head, Cardiovascular & Metabolism, Janssen Research & Development, LLC, in a company press release.
The new indication is based on results from the landmark phase 3 CREDENCE study (N=4401), which evaluated the efficacy and safety of canagliflozin vs placebo for adults with T2D and diabetic nephropathy.
Findings from CREDENCE demonstrated:
Canagliflozin also reduced the risk of secondary CV endpoints:
Adverse events and serious events were similar between groups but numerically lower in the cangliflozin group, according to a Janssen press release. The rates of diabetic ketoacidosis and genital mycotic infections were numerically higher in the group taking cangliflozin, as observed in other clinical trials. No difference was seen in lower limb amputation or bone fracture in this trial and there were no new safety signals.
Early detection key to slowing progression
According to the American Kidney Fund (AKF), T2D is responsible for 38% of all new cases of kidney disease. Kidney failure affects 37 million Americans.
“We know that the real battle to turn the tide on kidney disease is in early detection and slowing its progression so that patients stay healthier and fewer patients reach kidney failure,” said LaVarne A. Burton, AKF president and CEO.
Initially approved in 2013 for improving glycemic control in patients with type 2 diabetes, canagliflozin was subsequently approved in 2018 to reduce the risk of major adverse cardiovascular events, ie, myocardial infarction, stroke, and cardiovascular death. The SGLT-2 inhibitor was the first in class to receive the CV prevention indication.
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