The drug is the first heart failure medication to provide mortality benefit across the entire ejection fraction range.
AstraZeneca’s Forxiga (dapagliflozin) has been recommended by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency across the European Union (EU).
It involves the treatment of heart failure with reduced ejection fraction and covers patients across the full spectrum of left ventricular ejection fraction (LVEF), including heart failure with mildly reduced and preserved ejection fraction.
The positive opinion positive follows results from the DELIVER phase 3 trial – published in The New England Journal of Medicine – and data from a pre-specified pooled analysis of the DAPA-HF and DELIVER phase 3 trials published in Nature Medicine. The study demonstrated that Forxiga was the first heart failure medication to provide mortality benefit across the entire ejection fraction range.
Results from DELIVER research showed that Forxiga reduced the composite outcome of cardiovascular death or worsening of heart failure by 18%. Meanwhile, the treatment effect was consistent across the LVEF range, without evidence of attenuation of effect by LVEF.
In addition, the pre-specified, patient-level, pooled analysis of both the DELIVER and DAPA-HF phase 3 trials demonstrated that Forxiga reduced the risk of cardiovascular death by 14%.
Mene Pangalos, executive vice president, of BioPharmaceuticals R&D at AstraZeneca, commented: “Forxiga has already transformed the standard of care for millions of people in the EU living with heart failure.
“If approved for this new, broader indication for heart failure with mildly reduced or preserved ejection fraction, more patients will be able to benefit from this well-tolerated and guideline-directed treatment.”
He concluded: “As a leader in cardiorenal disease, AstraZeneca is committed to expanding heart failure treatment options, changing the way we treat this complex disease to improve patient outcomes.”
Heart failure remains a life-threatening disease in which the heart cannot pump enough blood around the body. It currently affects 15 million people in the EU alone.
Forxiga – known as Farxiga in the US – is approved for the treatment of patients with heart failure across more than 100 countries around the world including the US, the EU, China and Japan.