6th May 2020 08:13
(Alliance News) - Pharmaceutical firm AstraZeneca PLC on Wednesday said Farxiga has now been approved in the US to treat heart failure in adults.
Farxiga, the brand name for dapagliflozin, has been approved by the US Food & Drug Administration to reduce cardiovascular death and hospitalisation for heart failure in adults with heart failure who have reduced ejection fraction and do not have type-2 diabetes.
The approval was based on Astra's phase 3 DAPA-HF trial, which showed that Farxiga achieved "a statistically significant and clinically meaningful reduction" in cardiovascular death or hospitalisation for heart failure versus placebo.
The drug was granted priority review by the FDA earlier in 2020 after obtaining a fast track designation in September 2019. It is the first sodium glucose co-transporter 2 inhibitor to be approved by the FDA as a treatment for heart failure with reduced ejection fraction.
Reduced ejection fraction means that the left ventricle of the heart does not pump as well as it should, so the heart pumps less blood than needed.
AstraZeneca shares were up 1.7% early Wednesday in London at 8,656.00 pence.
By Anna Farley; [email protected]
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