The company has announced positive results from the landmark Phase III DAPA-HF trial which showed that Farxiga (dapagliflozin) met theprimary composite endpoint with a statistically-significant and clinically-meaningful reduction of cardiovascular death or the worsening of heart failure (defined as hospitalisation or an urgent heart failure visit), compared to placebo.
The trial was conducted in patients with reduced ejection fraction (HFrEF) on standard of care treatment, including those with and without type-2 diabetes. The safety profile of Farxiga in the DAPA-HF trial was consistent with the well-established safety profile of the medicine.
“With the DAPA-HF trial, Farxiga becomes the first in its class to demonstrate efficacy and safety data for the treatment of patients with heart failure, with and without type-2 diabetes, on top of standard of care. Today, half of heart failure patients will die within five years of diagnosis and it remains one of the leading causes of hospitalisation. We look forward to discussing the results of DAPA-HF with health authorities as soon as possible,” says Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca.
DAPA-HF is the first heart failure outcomes trial with an SGLT2 inhibitor investigating the treatment of heart failure in adults with HFrEF on top of standard of care(which includes medicines such as angiotensin-converting enzyme [ACE] inhibitors, angiotensin II receptor blockers [ARB], beta blockers, mineralocorticoid-receptor antagonists [MRAs] and neprilysin inhibitors), in patients with and without type-2 diabetes.
Farxiga is also being studied in patients with heart failure with preserved ejection fraction (HFpEF) in the DELIVER and DETERMINE (HFrEF and HFpEF) trials.
Photo of Mene Pangalos: AstraZeneca