AstraZeneca’s Farxiga (dapagliflozin) has been approved in the US to reduce the risk of cardiovascular (CV) death and hospitalization 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 Food and Drug Administration (FDA) was based on positive results from the Phase IIIDAPA-HF trial, which showed Farxiga achieving a statistically significant and clinically meaningful reduction of CV death or hospitalization 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 ≤ 40%).
“With the approval of Farxiga, we have reached a critical milestone to potentially transform heart failure treatment for the millions of people living with the condition in the US.We are now one step closer to making a significant impact on their lives by providing a much-needed treatment to help reduce their disease burden and live longer,” says Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca.
The DAPA-HF trial
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 hospitalization 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 hospitalzsation 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.
Farxiga is also indicated as an adjunct to diet and exercise to improve glycaemic control in adults with T2D.
Photo of Mene Pangalos: AstraZeneca