US regulators have approved AstraZeneca’s Farxiga (dapagliflozin) to cut the risk of cardiovascular (CV) death and hospitalisation for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction (HFrEF) with and without type II diabetes.
The approval was based on positive results from the landmark Phase III DAPA-HF trial, which showed that the drug reduced CV death or heart failure worsening, compared to placebo.
It follows the priority review designation granted by the FDA earlier this year and the Fast Track designation granted in September 2019.
In October 2019 the FDA approved Farxiga to reduce the risk of hospitalisation for HF in adult patients with T2D and established CV disease or multiple CV risk factors; with this approval, the drug is now the first sodium glucose co-transporter 2 (SGLT2) inhibitor approved in the country to treat patients with HFrEF.
“The ground-breaking results of the DAPA-HF trial have transformed heart failure therapeutics,” noted John McMurray, Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, UK.
Farxiga’s approval in this new setting “provides physicians with a completely novel pharmacological approach that greatly improves outcomes for patients with heart failure with reduced ejection fraction.”
