AstraZeneca has announced the securing of a Priority Review for its heart failure drug Farxiga (dapagliflozin), granted by the US Food and Drug Administration (FDA).
The US drug safety organisation accepted a supplemental New Drug Application (sNDA) for the treatment, which is indicated to reduce the risk of cardiovascular (CV) death or the worsening of heart failure (HF) in adults with heart failure with reduced ejection fraction (HFrEF) with and without type II diabetes (T2D).
The decision was allegedly based on results from the landmark Phase III DAPA-HF trial, in which the primary composite endpoint was time to the first occurrence of a worsening heart failure event. In the trial Farxiga demonstrated a reduced incidence of the composite outcome of CV death or the worsening of HF compared to placebo.
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.
The drug is “well established in the treatment of type II diabetes and this Priority Review shows its potential to also impact millions of patients with heart failure” explained Mene Pangalos, executive vice president, BioPharmaceuticals R&D.
He continued, “If approved, Farxiga will be the first and only medicine of its kind indicated to treat patients with heart failure.”
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.
