The US Food and Drug Administration (FDA) has granted Fast Track designation for the development of dapagliflozin (Farixga, AstraZeneca) to reduce the risk of cardiovascular death or the worsening of heart failure in adults with heart failure with reduced ejection fraction (HFrEF) or preserved ejection fraction (HFpEF). 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.
The Fast Track designation is based on two phase III trials—DAPA-HF and DELIVER—that investigated the role of dapagliflozin in patients with HFrEF and HFpEF respectively. A press release reports that the drug is currently approved as a monotherapy and as part of combination therapy to improve glycaemic control in adults with type 2 diabetes (T2D). In August, the FDA granted Fast Track designation for the development of the drug to delay the progression of renal failure and prevent cardiovascular disease and renal death in patients with chronic kidney disease. Dapagliflozin is not indicated to reduce the risk of heart failure, cardiovascular death death or kidney disease.
Mene Pangalos, executive vice president, BioPharmaceuticals R&D, says: “Heart failure affects approximately 64 million people worldwide, and about half will die within five years of diagnosis. This Fast Track designation for dapagliflozin 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 dapagliflozin as a potential new treatment option for heart failure patients.”