New data from a sub-analysis of AstraZeneca’s Phase III DAPA-HF trial has shown that Forxiga (dapagliflozin) reduced the incidence of the primary composite endpoint of heart failure (HF) worsening or cardiovascular (CV) death compared to placebo.
The drug demonstrated the results in patients with heart failure with reduced ejection fraction (HFrEF), irrespective of their background therapy (i.e. other medications for heart failure).
In the “landmark” trial, the drug was evaluated in patients who were receiving a broad range of pharmacological treatments, device therapies and cardiac resynchronisation therapy for HFrEF.
The new data from the DAPA-HF trial “further reinforce Forxiga’s clinical effects beyond diabetes” commented Mene Pangalos, executive vice president, BioPharmaceuticals R&D.
“By reducing the risk of heart failure worsening regardless of background therapy, Forxiga has the potential to improve current standard of care and reduce the burden of disease for heart failure patients across the globe.”
The results, which were announced at the American College of Cardiology’s 69th Annual Scientific Session, demonstrated a consistent reduction in the primary outcome – observed across all the treatment subgroups.
In January this year, AstraZeneca announced the securing of a Priority Review for Forxiga, granted by the US Food and Drug Administration (FDA). The US drug safety organisation accepted a supplemental New Drug Application (sNDA) for the treatment, based on results from DAPA-HF.
The first-in-class, oral once-daily SGLT2 inhibitor is already indicated as both monotherapy and as part of combination therapies to improve glycaemic control, with the additional benefits of weight loss and blood-pressure reduction, as an adjunct to diet and exercise in adults with type II.
In an additional statement, AstraZeneca has also revealed that its DAPA-CKD Phase III trial evaluating the drug in patients with chronic kidney disease (CKD) will be stopped early following a recommendation from an independent Data Monitoring Committee (DMC) based on its determination of overwhelming efficacy.
The company says that the decision to stop the trial early was made following a routine assessment of efficacy and safety which showed Forxiga’s benefits earlier than originally anticipated and AstraZeneca will now initiate closure of the trial.
Heart failure affects approximately 64 million people worldwide, of which at least half have a reduced ejection fraction. It is a chronic and degenerative disease where half of patients will die within five years of diagnosis.
