AstraZeneca's Farxiga Gets Fast Track Tag For Heart Failure
Zacks Investment Research | Sep 15, 2019 10:43PM ET
AstraZeneca PLC (NYSE:AZN) announced that the FDA has granted a Fast Track designation to its SGLT2 inhibitor Farxiga (dapagliflozin) for reducing the risk of cardiovascular (CV) death or worsening of heart failure in heart failure patients.
The blockbuster drug, approved to treat type II diabetes (T2D), is being evaluated in two phase III studies, namely DAPA-HF and DELIVER to see its effect in adults suffering heart failure with reduced ejection fraction (HFrEF) and preserved ejection fraction (HFpEF), respectively.
The FDA provides a Fast Track designation to help development and faster review of drugs, which treat serious and unmet medical conditions.
Last month, the FDA granted a Fast Track designation to Farxiga for chronic kidney disease (CKD). The drug is being evaluated in the phase III DAPA-CKD study to see its effect on renal outcomes and CV mortality in patients suffering CKD with or without type-2 diabetes (T2D).
All these studies are part of AstraZeneca's DapaCare clinical program to explore the CV, metabolic and renal profile of Farxiga in T2D patients. Farxiga is also being developed to treat patients with heart failure (HFrEF and HFpEF) in DETERMINE study.
Shares of AstraZeneca have rallied 12.6% so far this year against the Zacks Investment Research
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