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AstraZeneca’s leading diabetes medication could be approved to treat chronic kidney disease for patients with and without type 2 diabetes.
FDA granted dapagliflozin (Farxiga, AstraZeneca) Priority Review to treat new or new or worsening chronic kidney disease (CKD) in adults with and without type 2 diabetes (T2D).
Farxiga,a first-in-class, oral, once-daily sodium-glucose co-transporter-2 (SGLT2) inhibitor, has been used to improve glycemic control in adults with T2D for around 10 years, AstraZeneca said in a press release.
“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.,” said Mene Pangalos, executive vice president of BioPharmaceuticals R&D at AstraZeneca. “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.”
In the U.S., 37 million people are estimated to have CKD, and the condition is associated with a heightened risk of heart disease or stroke or the need for dialysis or kidney transplant.
FDA’s decision to grant Priority Review was based on a Phase 3 trial showing that Farxiga, on top of standard of care consisting of an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin receptor blocker (ARB), reduced the risk of the composite of worsening of renal function or risk of cardiovascular (CV) or renal death by 39% in patients with CKD Stages 2-4 and elevated urinary albumin excretion.
It also significantly reduced the risk of death from any cause by 31% compared to placebo, AstraZeneca said.
Last October, FDA granted Farxiga Breakthrough Therapy Designation in the U.S. for patients with CKD with and without T2D. FDA will set its Prescription Drug User Fee Action date for this indication for Farxiga during the second quarter.