AstraZeneca’s Farxiga granted Priority Review by FDA
AstraZeneca’s Farxiga (dapagliflozin) has been granted Priority Review in the US for the treatment of new or worsening chronic kidney disease (CKD) in adults with and without type-2 diabetes.
The FDA grants Priority Review to regulatory submissions for medicines that offer significant advances over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance. The Prescription Drug User Fee Action date, the day the FDA targets for their regulatory decision, will be during the second quarter of this year.
CKD is defined by decreased kidney function, and is often associated with a heightened risk of heart disease or stroke, or the need for dialysis or kidney transplant. CKD is expected to become the world’s fifth leading cause of mortality by 2040, with 37 million people in the US currently estimated to be living with the condition.
The FDA’s granting of Priority Review was based on clinical evidence from the DAPA-CKD Phase III trial. The trial showed 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 worsening renal function or risk of cardiovascular (CV) or renal death by 39%, compared with placebo in patients with CKD Stages 2-4 and elevated urinary albumin excretion.
The drug also significantly reduced the risk of death from any cause by 31% compared with placebo. The safety and tolerability of Farxiga were consistent with the well-established safety profile of the medicine.
Mene Pangalos, Executive Vice President of BioPharmaceuticals R&D, said: “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 US.
“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.”
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