Posted by Michael Wonder on 16 Sep 2019
FDA grants fast track designation for Farxiga in heart failure
16 September 2019 - AstraZeneca today announced that the US FDA has granted fast track designation for the development of Farxiga (dapagliflozin) to reduce the risk of cardiovascular death, or the worsening of heart failure, in adults with heart failure with reduced ejection fraction or preserved ejection fraction.
The Fast Track designation is based on two Phase III trials, DAPA-HF and DELIVER, which investigated the role of Farxiga in patients with heart failure with reduced ejection fraction and preserved ejection fraction, respectively.
