AstraZeneca’s Farxiga meets Phase 3 primary endpoint in heart failure

pharmafile | August 20, 2019 | News story | Manufacturing and Production, Sales and Marketing AstraZeneca, cardiovascular disease, farxiga 

New Phase 3 data has been unveiled for AstraZeneca’s Farxiga (dapagliflozin), confirming that the SGLT2 inhibitor met its primary composite endpoint when added to standard of care by achieving 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 data was derived from a study comprised of patients with reduced ejection fraction (HFrEF) when given standard of care treatment, including those with and without type-2 diabetes. The trial was the first to investigate an SGLT2 inhibitor in addition to standard of care in a representative patient population with and without type-2 diabetes.

“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,” explained Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D. “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.”

Dr John McMurray, of the University of Glasgow’s Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, added: “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. 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.”

While detailed findings of the study were not revealed, AZ confirmed that full results would be presented at an upcoming medical conference.

Matt Fellows

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