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FDA gives a priority review for key heart failure drug Farxiga

Published on 06/01/20 at 12:49pm

The FDA has accepted a New Drug Application (sNDA) and has granted a priority review for AstraZeneca's drug Farxiga (dapagliflozin) to reduce the risk of heart failure (HF) and cardiovascular death.

This sNDA and the priority review is based on results from Phase III trials published in The New England Journal of Medicine back in September 2019. This shows that Farxiga is reduced the incidence of the composite outcome of CV death or the worsening of HF versus placebo.

Farxiga has been fast tracked twice already, back in September 2019 for the treatment of heart failure and in August 2019 to delay the progression of renal failure in patients with chronic kidney disease, with and without T2D. It was also approved by the FDA in October 2019, to reduce the risk of hospitalisation for heart failure in patients with T2D, and established cardiovascular disease or multiple CV risk factors.

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D at AstraZeneca, said: “Farxiga is well established in the treatment of type-2 diabetes and this Priority Review shows it’s 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 SGLT2 inhibitor indicated as both a monotherapy and as a part of combination therapies to improve glycaemic control.

Heart Failure is a life threatening disease in which the heart cannot pump enough blood.  

Conor Kavanagh

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