AstraZeneca upbeat on latest 'Forxiga' trial outcomes
AstraZeneca announced positive results from its phase 3 ‘DAPA-HF’ trial on Tuesday, which showed that ‘Farxiga’ (dapagliflozin) met the primary composite endpoint with a statistically-significant and clinically-meaningful reduction of cardiovascular death or worsening of heart failure - defined as hospitalisation or an urgent heart failure visit - compared to placebo.
The FTSE 100 pharmaceuticals giant said the trial was conducted in patients with reduced ejection fraction (HFrEF) on standard-of-care treatment, including those with and without type-2 diabetes.
It said 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,” said AstraZeneca’s executive vice-president of biopharmaceuticals research and development, Mene Pangalos.
“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.”
The company said DAPA-HF was 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, in patients with and without type-2 diabetes.
Standard of care includes medicines such as angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARB), beta blockers, mineralocorticoid-receptor antagonists (MRAs) and neprilysin inhibitors.
“The benefits of dapagliflozin in DAPA-HF are very impressive, with a substantial reduction in the primary composite outcome of cardiovascular death or hospital admission,” said John McMurray, MD, of the University of Glasgow Cardiovascular Research Centre and the Institute of Cardiovascular and Medical Sciences.
“We hope these exciting new findings will ultimately help reduce the terrible burden of disease caused by heart failure and help improve outcomes for our patients.”
AstraZeneca said the full DAPA-HF trial results would be submitted for presentation at a forthcoming medical meeting.
It said Farxiga was also being studied in patients with heart failure with preserved ejection fraction (HFpEF) in the ‘DELIVER’ and ‘DETERMINE’ (HFrEF and HFpEF) trials.