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FDA Approves Dapagliflozin (Farxiga) for Chronic Kidney Disease
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FDA approves new drug for treatment of adults with chronic kidney disease
Today, the U.S. Food and Drug Administration approved Farxiga (dapagliflozin) oral tablets to reduce the risk of kidney function decline, kidney failure, cardiovascular death and hospitalization for heart failure in adults with chronic kidney disease who are at risk of disease progression.
Chronic kidney disease is an important public health issue, and there is a significant unmet need for therapies that slow disease progression and improve outcomes. Today s approval of Farxiga for the treatment of chronic kidney disease is an important step forward in helping people living with kidney disease.
FDA expanded the indication for dapagliflozin (Farxiga) into chronic kidney disease (CKD).
The drug, which first entered the market for type 2 diabetes in 2014, was approved to reduce the risk of kidney function decline, kidney failure, cardiovascular death, and hospitalization for heart failure in adults with CKD at risk of progression.
CKD has a significant unmet need for therapies that slow disease progression and improve outcomes, said Aliza Thompson, MD, deputy director of the Division of Cardiology and Nephrology at the FDA s Center for Drug Evaluation and Research, in a statement. Today s approval of Farxiga for the treatment of chronic kidney disease is an important step forward in helping people living with kidney disease.