Jan 06, 2019: AstraZeneca announced the U.S. FDA has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for Farxiga (dapagliflozin) in order to reduce the risk of cardiovascular (CV) death or the worsening of heart failure (HF) in adults with heart failure and reduced ejection fraction (HFrEF) with and without type-2 diabetes (T2D).
Farxiga is the first-in-class, oral once-daily selective inhibitor of human sodium-glucose co-transporter 2 (SGLT2).
The sNDA was based on the results from the landmark Phase III DAPA-HF trial published in Sep 2019 in The New England Journal of Medicine, which showed Farxiga on top of standard of care reduced the incidence of the complex result of CV death or the worsening of HF versus placebo.
Farxiga is indicated as a monotherapy and as part of combination therapies in order to improve glycaemic control in adults with T2D. In October 2019, the FDA also approved Farxiga to reduce the risk of hospitalisation for the heart failure in patients with T2D and established cardiovascular disease or multiple CV risk factors. https://www.astrazeneca.com/media-centre/press-releases/2020/farxiga-granted-fda-priority-review-for-patients-with-heart-failure-with-reduced-ejection-fraction-06012020.html