AstraZeneca Forxiga recommended for nod in EU for chronic heart failure

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on results from the DELIVER Phase III trial, published in The New England Journal of Medicine and results from a pre-specified, patient-level, pooled analysis of the DAPA-HF and DELIVER Phase III trials published in Nature Medicine. The pooled analysis showed Forxiga to be the first HF medication to demonstrate mortality benefit across the full ejection fraction range.

HF is a life-threatening chronic disease in which the heart cannot pump enough blood around the body, affecting 15 million people in the EU. Patients with HFmrEF or HFpEF experience an especially high burden of symptoms and physical limitations, and a poor quality of life, which is why improving health status is a key goal of management.

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: "Forxiga has already transformed the standard of care for millions of people in the EU living with heart failure. If approved for this new, broader indication for heart failure with mildly reduced or preserved ejection fraction, more patients will be able to benefit from this well-tolerated and guideline-directed treatment. As a leader in cardiorenal disease, AstraZeneca is committed to expanding heart failure treatment options, changing the way we treat this complex disease to improve patient outcomes."

The CHMP recommendation states Forxiga is indicated in adults for the treatment of symptomatic chronic HF.

Results from the DELIVER Phase III trial in patients with HFpEF and HFmrEF showed that Forxiga reduced the composite outcome of cardiovascular (CV) death or worsening of HF by 18% (16.4% in the dapagliflozin group and 19.5% in the placebo group [p<0.001, absolute risk reduction [ARR] 3.1%] over a median follow-up of 2.3 years). The treatment effect was consistent across the LVEF range, without evidence of attenuation of effect by LVEF. Additionally, the pre-specified, patient-level, pooled analysis of the DELIVER and DAPA-HF Phase III trials demonstrated that Forxiga reduced the risk of CV death by 14% (p=0.01, ARR 1.5%), death from any cause by 10% (p=0.03, ARR 1.5%), and total (first and repeat) hospitalisation for HF (hHF) by 29% (p<0.001, ARR 6%) over the median follow-up of 22 months2.

Forxiga (known as Farxiga in the US) is approved for the treatment of patients with HFrEF in more than 100 countries around the world including the US, the EU, China, and Japan. It was most recently approved in Great Britain and Turkey to extend the HF indication to include patients across the full spectrum of left ventricular ejection fraction. The HF indication extension application is currently under review in the US and other countries.