
FDA Grants Priority Review to Dapagliflozin for CKD
The FDA decision on dapaglifozin for CKD is expected in the second quarter of 2021.
The FDA granted Priority Review for AstraZeneca’s dapagliflozin (Farxiga), which could become the first sodium glucose co-transporter 2 (SGLT2) inhibitor approved to treat patients with
The FDA is expected to make decision during the second quarter of 2021, according to a
SGLT2 inhibitors were originally developed to treat T2D and function by targeting a protein that blocks the body’s ability to reabsorb excess glucose and instead cause it to be expelled from the body in urine. SGLT2 inhibitors have also been shown to reduce the risk of heart failure. Specifically, dapagliflozin was approved to reduce the risk of hospitalization for heart failure in patients with T2D and established cardiovascular (CV) disease or multiple CV risk factors.
Risk of developing heart disease is often associated with CKD. CKD is expected to be the fifth leading cause of death in the world by 2040 and currently impacts an estimated 37 million Americans.
Dapagliflozin
The findings were presented
“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,” said Mene Pangalos, executive vice president of Biopharmaceuticals Research and Development.
In May 2020, the FDA
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