AstraZeneca's Farxiga nears new indication with priority review status
Anglo-Swedish pharma major AstraZeneca’s (LSE: AZN) Farxiga (dapagliflozin) is closer to US approval in a new indication.
The US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for the SGLT2 inhibitor to reduce the risk of cardiovascular (CV) death or the worsening of heart failure (HF) in adults with HF with reduced ejection fraction (HFrEF), with and without type-2 diabetes (T2D).
A Prescription Drug User Fee Act date has been set for the second quarter of 2020.
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