(Alliance News) - Farxiga has been approved by the US Food & Drug Administration for treatment of chronic kidney disease, AstraZeneca PLC said late Friday.
The approval of Farxiga, whose generic name is dapagliflozin, "is the most significant advancement in the treatment of chronic kidney disease in more than 20 years," the Cambridge, England-based pharmaceutical firm said.
The US approval was based on positive results from the DAPA-CKD Phase III trial, AstraZeneca said, and follows the grant of a priority review by the FDA earlier this year.
The approval of Farxiga was for the reduction in the risk of sustained estimated glomerular filtration rate decline, end-stage kidney disease, cardiovascular death and hospitalisation for heart failure in adults with chronic kidney disease at risk of progression. Some 37 million people in the US have chronic kidney disease, Astra noted.
"Today's approval is the most significant advancement in the treatment of chronic kidney disease in more than 20 years," said Mene Pangalos, executive vice president of BioPharmaceuticals R&D at AstraZeneca. "We've shown impressive efficacy for Farxiga in type-2 diabetes, heart failure with reduced ejection fraction and, most recently, chronic kidney disease, and we are thrilled to be able to bring this medicine to millions of patients in the US."
By Tom Waite; thomaslwaite@alliancenews.com
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Astrazeneca (AZN)