AstraZeneca’s Farxiga (dapagliflozin) has met the primary endpoint in Phase III DAPA-HF study involving patients with reduced ejection fraction (HFrEF), with or without type 2 diabetes.
Compared to placebo, the drug showed a statistically-significant and clinically-meaningful decrease in cardiovascular death or the worsening of heart failure when given in addition to standard of care.
The safety profile of the drug was also observed to be consistent with its established profile.
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.”
Farxiga is an oral, once-daily sodium-glucose transport protein 2 (SGLT2) inhibitor being developed as a single agent and combination therapy to improve glycaemic control.
In adjunction with diet and exercise, the drug also helps in weight loss and blood-pressure reduction in type 2 diabetes patients.
The international, multi-centre, parallel-group, randomised, double-blind DAPA-HF study assessed a 10mg dose of the drug.
It is said to be the first heart failure trial to investigate an SGLT2 inhibitor given in addition to standard of care in subjects with and without type-2 diabetes.
DAPA-HF forms part of the DapaCare clinical programme designed to study Farxiga’s cardiovascular (CV) and renal profile in approximately 30,000 patients with and without type-2 diabetes.
The drug is also being evaluated in heart failure patients participating in the DELIVER and DETERMINE studies, as well as in chronic kidney disease patients in the DAPA-CKD trial.