AstraZeneca Announces Positive Results from Farxiga Phase III Trial

August 23, 2019

AstraZeneca announced that its therapy for the treatment of patients with heart failure, Farxiga (dapagliflozin), has met the DAPA-HF trial primary endpoint.

In an Aug. 20, 2019 press release, AstraZeneca announced that its therapy for the treatment of patients with heart failure, Farxiga (dapagliflozin), has met the primary endpoint, according to results of the Phase III Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure (DAPA-HF) trial.

The primary composite endpoint of the trial was considered to be the amount of time taken before the patient experienced a worsening heart failure event or cardiovascular death. According to the results, Farxiga successfully met the primary endpoint by demonstrating a reduction in cardiovascular death or worsening of heart failure to a statistically significant and clinically meaningful level when compared with placebo treatment. Patients included in the trial were those with reduced ejection fraction (HFrEF) on standard treatment, irrespective of whether they had type-2 diabetes or not.

“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 Mene Pangalos, executive vice-president, BioPharmaceuticals R&D, in the press release. “Today, half of heart failure patients will die within five years of diagnosis and it remains one of the leading causes of hospitalization. We look forward to discussing the results of DAPA-HF with health authorities as soon as possible.”

John McMurray, MD, University of Glasgow, 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.”

Farxiga is an SGLT2 inhibitor that should be taken once daily, orally, and can either be administered as a monotherapy or in combination. It is used to improve glycemic control and is currently being developed for patients with heart failure.

Source: AstraZeneca