The US Food and Drug Administration on Friday 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.
The FDA granted the approval of Farxiga to Anglo-Swedish pharma major AstraZeneca (LSE: AZN). Farxiga, which was originally approved in 2014 to improve glycemic control in adults with type 2 diabetes in addition to diet and exercise, is the first SGLT2 inhibitor proven to significantly prolong the survival of patients with chronic kidney disease with and without type 2 diabetes.
AstraZeneca beat Eli Lilly (NYSE: LLY) and Boehringer Ingelheim’s SGLT2 rival Jardiance (empagliflozin) in gaining approval for this indication, as the US/Germany pair are not expected to provide Jardiance data in the kidney disease setting until next year.
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