The fast track designation is for the use of Farxiga in reducing the chances of cardiovascular (CV) death, or the worsening of heart failure, in adults with heart failure with reduced ejection fraction (HFrEF), or preserved ejection fraction (HFpEF).
Farxiga is an oral, daily once selective inhibitor of human sodium-glucose co-transporter 2 (SGLT2). It has been approved in the US as monotherapy and also in combination therapy to boost glycaemic control, as an adjunct to diet and exercise in adults with type-2 diabetes.
The FDA’s fast track programme is designed to speed up the development and review of new drugs for the treatment of serious conditions where there is an unmet treatment need.
AstraZeneca biopharmaceuticals R&D executive vice president Mene Pangalos said: “Heart failure affects approximately 64 million people worldwide, and about half will die within five years of diagnosis.
“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.”
The fast track status for the AstraZeneca SGLT2 inhibitor is based on the findings of two phase 3 trials – DAPA-HF and DELIVER. The two late-stage trials probed the role of Farxiga in patients having heart failure with HFrEF and HFpEF, respectively.
Last month, AstraZeneca said that Farxiga met the primary composite endpoint in the DAPA-HF trial. The SGLT2 inhibitor delivered a statistically-significant and clinically-meaningful reduction of cardiovascular death or the worsening of heart failure, in comparison to placebo in the late-stage trial.
In September 2018, Farxiga succeeded in a phase 3 CV outcomes trial, called DECLARE-TIMI 58, by delivering a statistically-significant reduction in hospitalization for heart failure or CV death in patients with type-2 diabetes.
Last month, the AstraZeneca drug was given fast track designation by the FDA for its use to delay the progression of renal failure and prevent CV and renal death in patients having chronic kidney disease.