9th May 2023 09:09
(Alliance News) - AstraZeneca PLC on Tuesday said its Farxiga drug has been approved by the US Food & Drug Administration to reduce the risk of cardiovascular death and hospitalisation for heart failure in adults.
The Cambridge, UK-based pharmaceutical firm said the approval of the treatment was due to positive results from its DELIVER phase 3 trial.
Farxiga, an inhibitor of the sodium-glucose cotransporter 2 protein, is a an approved treatment for type-2 diabetes, and has also been approved in the US for adults with heart failure with reduced ejection fraction.
The firm said data from the phase 3 trial indicated that Farxiga caused an early reduction in the primary endpoint of cardiovascular death, or worsening heart failure.
Results also showed that the treatment effect of the drug was consistent across the left ventricular ejection fraction range, making Farxiga the first SGLT2 treatment to show a mortality benefit.
Ruud Dobber, executive vice-president of the BioPharmaceuticals business unit at 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."
AstraZeneca shares rose 0.1% to 11,884.00 pence each in London on Tuesday morning.
By Harvey Dorset, Alliance News reporter
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