Posted by Michael Wonder on 06 Jan 2020
Farxiga granted FDA priority review for patients with heart failure with reduced ejection fraction
6 January 2020 - AstraZeneca today announced the US FDA has accepted a supplemental new drug application and granted Priority Review for Farxiga (dapagliflozin) to reduce the risk of cardiovascular death or the worsening of heart failure in adults with heart failure with reduced ejection fraction with and without type 2 diabetes mellitus.
Farxiga is a first-in-class, oral once-daily selective inhibitor of human sodium-glucose co-transporter 2.
The Prescription Drug User Fee Act date, the FDA action date for this supplemental application, is scheduled for the second quarter of 2020.
