AstraZeneca’s heart failure treatment Farxiga (dapagliflozin) has achieved the primary composite endpoint in the phase III DAPA-HF study.
The Dapagliflozin and prevention of adverse-outcomes in heart failure (DAPA-HF) study demonstrated Farxiga’s potential with a statistically-significant and clinically-meaningful reduction of cardiovascular death or the declining of heart failure compared against placebo.
Farxiga is a first-in-class and oral once-daily SGLT2 inhibitor specified as both monotherapy and as part of combination therapy to enhance glycaemic control.
AstraZeneca carried out the trial in patients with reduced ejection fraction (HFrEF) on the standard of care treatment, including those with and without type-2 diabetes.
DAPA-HF is claimed to be the first heart failure outcomes study with an SGLT2 inhibitor evaluating the treatment of heart failure in adults with HFrEF on top of standard of care.
It is an international, multi-centre, parallel group, randomised, and double-blind trial in patients with heart failure and reduced ejection fraction (LVEF ≤ 40%), with and without type-2 diabetes.
The study has been designed to evaluate the effect of Farxiga 10mg, compared with placebo, given once daily in addition to standard of care.
The company is also evaluating the Farxiga in patients with heart failure with preserved ejection fraction (HFpEF) in the Deliver and Determine (HFrEF and HFpEF) trials.
AstraZeneca biopharmaceuticals R&D executive vice president Mene Pangalos said: “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.”
Recently, AstraZeneca has announced positive OS results from the phase III randomised, double-blinded and multi-centre trial of Tagrisso in previously-untreated patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have EGFR mutations.