FDA Gives AstraZeneca’s Farxiga Breakthrough Status for Chronic Kidney Disease

The FDA has granted AstraZeneca’s Farxiga a Breakthrough Therapy designation for the treatment of patients with chronic kidney disease (CKD) even if they don’t suffer from type 2 diabetes, the drug’s original indication from 2014.

In a phase 3 study, the drug reduced the risk of worsening renal function or cardiovascular death by 39 percent and death associated with any cause decreased by 31 percent vs. placebo.

Affecting 37 million people in the U.S., CKD is a progressive illness marked by decreased renal function and is commonly associated with heart failure. Last October, Farxiga gained the FDA’s approval for treating heart failure patients with type 2 diabetes.