Just weeks after it fast-tracked dapagliflozin for the treatment of chronic kidney disease (CKD), the FDA announced it was granting Fast Track status to the drug for another indication: heart failure.
Dapagliflozin, sold as Farxiga by U.K.-based drugmaker AstraZeneca, is currently approved as a monotherapy or part of combination therapy to improve glycemic control in adults with type 2 diabetes, according to a statement. The FDA announced in August it was fast-tracking dapagliflozin to delay the progression of renal failure and prevent CV death and renal death in those with CKD.
Now, the medication is also being studied as a solution for reducing the risk of CV death or worsening heart failure in those with HF with reduced or preserved ejection fraction. The Fast Track designation is based on two Phase III trials—DAPA-HF and DELIVER—which looked at the role of dapagliflozin in patients with HFrEF and HFpEF, respectively.
“Heart failure affects approximately 64 million people worldwide, and about half will die within five years of diagnosis,” Mene Pangalos, executive VP of BioPharmaceuticals R&D at AstraZeneca, said in a statement. “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.”