AstraZeneca’s (AZ) Farixga (dapagliflozin) has been approved for extended use in the US, meaning adult patients with heart failure (HF) can benefit from the treatment regardless of their left ventricular ejection fraction status (LVEF).
Farxiga, sold as Forxiga in certain markets, was previously approved in the US for HF patients with reduced ejection fraction (HFrEF) which is equal to or less than 40%.
HF affects approximately seven million people in the US and is associated with substantial morbidity and mortality, with chronic HF the leading cause of hospitalisation for those over the age of 65.
Roughly half of all HF patients have mildly reduced ejection fraction (HFmrEF) or preserved ejection fraction (HFpEF), with few therapeutic options available.
As well as the greater risk of death and hospitalisations, patients with HFmrEF or HFpEF experience an especially high burden of symptoms and physical limitations.
The US Food and Drug Administration’s (FDA) decision was supported by results from AZ’s phase 3 DELIVER trial, which evaluated Farixga in HF patients with LVEF greater than 40%, with or without type 2 diabetes.
The study showed that Farixga, in addition to standard care, improved symptom burden, physical limitations and quality of life compared to placebo, with benefits achieved from as early as one month and sustained at eight.
Also at eight months, fewer patients treated with Farixga had a significant deterioration compared to placebo, and more had at least small, moderate and large improvements in health status.
Ruud Dobber, executive vice-president, BioPharmaceuticals Business Unit, AstraZeneca, said: “Approximately half of heart failure patients die within five years of diagnosis, highlighting an urgent unmet need for well-tolerated treatment options that can bring life-saving benefits and reduce the risk of cardiovascular death.”
Dobber added that the approval “will help patients across the full spectrum of heart failure lead healthier lives.”
Farxiga is already approved to treat patients with type 2 diabetes, HFrEF and chronic kidney disease in over 100 countries, including the US, EU, China and Japan.
As well as this most recent US approval, Farixga has also been approved in the EU, Great Britain, Japan and Turkey to extend the HF indication to include patients across the full spectrum of LVEF.