Farxiga approved in the US for the treatment of heart failure in patients with heart failure with reduced ejection fraction.- AstraZeneca

AstraZeneca’s Farxiga (dapagliflozin) has been approved in the US to reduce 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-2 diabetes (T2D).The approval by the FDA was based on positive results from the landmark Phase III DAPA-HF trial, which showed Farxiga achieving a statistically significant and clinically meaningful reduction of CV death or hospitalisation for heart failure (HF), compared to placebo.

The decision follows the Priority Review designation granted by the FDA earlier this year and the Fast Track designation granted in September 2019.Farxiga is the first sodium glucose co-transporter 2 (SGLT2) inhibitor approved by the US FDA indicated to treat patients with HFrEF (LVEF less than 40%).

The DAPA-HF trial showed that Farxiga, in addition to standard of care, reduced the risk of the composite outcome of CV death or the worsening of HF versus placebo by 26% (absolute risk reduction [ARR] = 5% [event rate/100 patient years: 11.6 vs 15.6, respectively]; p<0.0001) in patients with HFrEF. During the trial duration, one CV death or hospitalisation for HF or an urgent visit associated with HF could be avoided for every 21 patients treated with Farxiga.

The safety profile of Farxiga in the DAPA-HF trial was consistent with the well-established safety profile of the medicine. The data from the DAPA-HF trial were published in The New England Journal of Medicine.

In October 2019 the US 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. The approval was based on the DECLARE-TIMI 58 trial.

See-“Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction”- John J.V. McMurray, M.D., Scott D. Solomon, M.D., Silvio E. Inzucchi, M.D., et al., for the DAPA-HF Trial Committees and Investigators*-November 21, 2019
N Engl J Med 2019; 381:1995-2008
DOI: 10.1056/NEJMoa1911303.