AstraZeneca’s (AZ) Forixga (dapagliflozin) has been approved for extended use in the EU, with its indication now covering heart failure patients across the full spectrum of left ventricular ejection fraction (LVEF), including those with mildly reduced and preserved ejection fraction.
Heart failure affects approximately 64 million people globally and is associated with substantial morbidity and mortality, with chronic heart failure the leading cause of hospitalisation for those over the age of 65.
Of the estimated 64 million heart failure patients, roughly half have reduced ejection fraction – the measurement of the heart’s ability to pump oxygen-rich blood into the body – which is equal to or less than 40%. The remainder have mildly reduced or preserved ejection fraction.
As well as the greater risk of death and hospitalisations, patients with heart failure and mildly reduced or preserved ejection fraction experience an especially high burden of symptoms and physical limitations.
The European Commission’s decision, which follows a recommendation from the Committee for Medicinal Products for Human Use in December last year, is supported by results from AZ’s phase 3 DELIVER trial, which evaluated the Forixga in HF patients with LVEF greater than 40%, with or without type 2 diabetes.
The study showed that Forixga, 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 Forixga had a significant deterioration compared to placebo, and more had at least small, moderate and large improvements in health status.
Mene Pangalos, executive vice president, BioPharmaceuticals R&D, AZ, said: “This broader indication for Forxiga for the treatment of symptomatic chronic heart failure across the full ejection fraction range will help more patients to benefit from this well-tolerated and guideline-directed treatment.”
Forxiga, marketed as Farxiga in the US, is already approved to treat patients with type 2 diabetes, reduced ejection fraction and chronic kidney disease in over 100 countries, including the US, EU, China and Japan.
As well as this most recent EU approval, Forixga has also been approved in Great Britain, Japan and Turkey to extend the HF indication to include patients across the full spectrum of LVEF and the HF indication extension application is currently under review in the US and other countries.