FDA grants priority review to Farxiga for treatment of CKD
The FDA has granted priority review to Farxiga, from AstraZeneca, for the treatment of chronic kidney disease.
If approved, it would be the first SGLT2 inhibitor on the market to treat this patient population, according to a press release.
The action by the FDA stems from results of the DAPA-CKD phase 3 trial, according to the release, which demonstrated Farxiga (dapagliflozin) reduced the risk for worsening kidney function or risk for mortality from cardiovascular or kidney complications by 39% compared with placebo.
The drug could be used to treat patients with and those without diabetes.
“This decision brings us a step closer to delivering this new treatment option for the millions of patients living with chronic kidney disease in the U.S.,” Mene Pangalos, executive vice president of BioPharmaceuticals R&D, said in the release. “Farxiga has the potential to be a truly transformational medicine across a breadth of diseases, including type-2 diabetes, heart failure with reduced ejection fraction and, if approved, chronic kidney disease.”