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2023 | HFSA

FARXIGA extended in the US to reduce risk of cardiovascular death and hospitalization for heart failure to a broader range of patients

Industry News Industry

AstraZeneca’s FARXIGA (dapagliflozin) has been approved in the US to reduce the risk of cardiovascular (CV) death, hospitalization for heart failure (hHF) and urgent heart failure (HF) visits in adults with HF. The approval by the Food and Drug Administration (FDA) was based on positive results from the DELIVER Phase III trial.1 FARXIGA was previously approved in the US for adults with HF with reduced ejection fraction (HFrEF).

Ruud Dobber, Executive Vice-President, BioPharmaceuticals Business Unit, AstraZeneca, said: “Approximately half of heart failure patients die within five years of diagnosis, highlighting an urgent unmet need for well-tolerated treatment options that can bring life-saving benefits and reduce the risk of cardiovascular death. The approval of FARXIGA in the US not only reinforces AstraZeneca’s commitment to reducing the burden of this complex and life-threatening disease, but will help patients across the full spectrum of heart failure lead healthier lives.”

HF is a chronic, long-term condition that worsens over time2 and affects almost seven million people in the US.3 It is also the leading cause of hospitalization for those over 65 years and represents a significant clinical and economic burden.4 Approximately half of all HF patients have HF with mildly reduced ejection fraction (HFmrEF) or HF with preserved ejection fraction (HFpEF)5 and these patients are not only at greater risk of death and hospitalizations but experience an especially high burden of symptoms and physical limitations, and a poor quality of life.6