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Fast Track designation given to heart failure treatment

Farxiga (dapagliflozin) has been given Fast Track designation by the FDA to reduce the risk of cardiovascular death.

The US Food and Drug Administration (FDA) has granted Fast Track designation for the development of AstraZeneca’s Farxiga (dapagliflozin). This treatment is to reduce the risk of cardiovascular (CV) death, or the worsening of heart failure, for adults with heart failure with reduced ejection fraction (HFrEF) or preserved ejection fraction (HFpEF).

“Heart failure affects approximately 64 million people worldwide and about half will die within five years of diagnosis,” said Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D. “This Fast Track designation for Farxiga brings us closer to fulfilling our ambition to help prevent, treat and cure heart failure and we look forward to working with the FDA to explore Farxiga as a potential new treatment option for heart failure patients.”

This designation is based on two Phase III trials, DAPA-HF and DELIVER, which investigated the role of Farxiga in patients with heart failure with reduced ejection fraction (HFrEF) and preserved ejection fraction (HFpEF), respectively.

Farxiga is currently approved as a monotherapy and as part of combination therapy to improve glycaemic control in adults with type 2 diabetes (T2D).

Farxiga has also recently been granted Fast Track designation to delay the progression of renal failure and prevent cardiovascular (CV) and renal death in patients with chronic kidney disease (CKD).

The FDA’s Fast Track programme is designed to accelerate the development and review of new medicines for the treatment of serious conditions where there is an unmet treatment need.

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