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January 6, 2020

AstraZeneca secures FDA priority review for Farxiga

AstraZeneca has secured the US Food and Drug Administration (FDA) priority review for Farxiga (dapagliflozin) to treat heart failure with reduced ejection fraction (HFrEF).

AstraZeneca has secured the US Food and Drug Administration (FDA) priority review for Farxiga (dapagliflozin) to treat heart failure with reduced ejection fraction (HFrEF).

The US regulator accepted a supplemental New Drug Application (sNDA) granting priority review for Farxiga that seeks to reduce the risk of cardiovascular (CV) death and heart failures (HF) in adults with and without type-2 diabetes (T2D).

The sNDA comes from results of the Phase III DAPA-HF trial published in September last year in The New England Journal of Medicine .

AstraZeneca BioPharmaceuticals R&D executive vice-president Mene Pangalos said: “Farxiga is well established in the treatment of type-2 diabetes and this Priority Review shows its potential to also impact millions of patients with heart failure.

“If approved, Farxiga will be the first and only medicine of its kind indicated to treat patients with heart failure.”

Farxiga is an oral once-daily selective sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as monotherapy or in combination to improve glycaemic control. The drug also supports weight loss and lowers blood pressure.

Farxiga completed more than 35 clinical trials, excluding ongoing Phase IIb / III trials, with testing on more than 35,000 patients overall.

In August last year, FDA granted Fast Track designation for Farxiga development to delay renal failure progression, prevent CV and renal death in patients suffering from chronic kidney disease.

A month later, the regulator awarded another Fast Track designation for the development of Farxiga in HF.

Notably, AstraZeneca divested Arimidex and Casodex rights recently to French pharmaceutical company Juvisé Pharmaceuticals for $181m.

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