New data from AstraZeneca has shown that Farxiga (dapagliflozin) reduces the worsening heart failure (HF) - defined as hospitalisation or an urgent visit, or death from cardiovascular (CV) causes – compared to placebo, when added to standard of care.
In the landmark Phase III DAPA-HF trial, the drug reached the primary composite outcome – marking the success of the first trial with an SGLT2 inhibitor investigating the treatment of HF in patients with reduced ejection fraction (HFrEF), with and without type II diabetes.
The company confirmed that the new analyses showed the consistency of these results across patient subgroups with and without the disease, an early onset of effects, and improvement in patient-reported outcomes of HF-related health status.
The data, which were presented at the American Heart Association (AHA) Scientific Sessions in Philadelphia, showed improvements versus placebo in the worsening or progression of the disease and improved patient-reported symptoms and quality of life.
More specifically, the relative risk of the composite of worsening of HF or CV death was reduced by 27% when using Farxiga among participants without diabetes, and 25% in patients with diabetes, suggesting that the drug could be an effective treatment for patients with HFrEF both with and without diabetes.
Heart failure affects approximately 64 million people around the world and “about half of those patients will die within five years of diagnosis,” explained Elisabeth Björk, senior vice president at BioPharmaceuticals.
She continued, “These new analyses from the DAPA-HF trial reinforce the science behind Farxiga as clinically significant across heart failure patient populations and suggest the potential to improve the current standard of care for millions of these patients.”
The results build on the DAPA-HF detailed results announced in September this year, as well as the US Food and Drug Administration (FDA) Fast Track designation.
The drug, a first-in-class, oral once-daily SGLT2 inhibitor, has a “robust” programme of clinical trials that includes more than 35 completed and ongoing Phase IIb/III trials in more than 35,000 patients, as well as more than 2.5 million patient-years’ experience.