Forxiga recommended for approval in the EU by CHMP for heart failure

AstraZeneca’s Forxiga (dapagliflozin) has been recommended for an indication extension of its marketing authorisation in the European Union (EU) for the treatment of symptomatic chronic heart failure with reduced ejection fraction (HFrEF) in adults with and without type-2 diabetes (T2D). Heart failure (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, at least half of which have a reduced ejection fraction.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the landmark DAPA-HF Phase III trial, published in The New England Journal of Medicine.

Forxiga is the first SGLT2 inhibitor to have shown a statistically significant reduction in the risk of cardiovascular (CV) death or worsening of HF events (including hospitalisation for HF, hHF) versus placebo where both components of the primary composite endpoint contributed benefit to the overall effect. In the DAPA-HF Phase III trial, the safety profile of Forxiga was consistent with the well-established safety profile of the medicine.

John McMurray, MD, Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, UK, said: “I am delighted that we may soon have a new treatment that is effective, safe and simple to use for patients with heart failure with reduced ejection fraction. Dapagliflozin is a major and welcome breakthrough with the potential to improve not only the quality, but also importantly, the length of life for millions of people suffering from this terrible disease in Europe and throughout the world.”

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “The unmet need for novel medicines in heart failure remains high, with more than half of patients expected to die within five years of diagnosis. Novel treatment options reducing cardiovascular death and hospitalisation, in addition to improving symptoms, are urgently needed. With the positive opinion for Forxiga we are one step closer to transforming the standard of care for millions of people in the EU living with heart failure.”

The DAPA-HF Phase III trial demonstrated that Forxiga, in addition to standard of care, reduced the risk of the composite outcome of CV death or the worsening of HF versus placebo by 26% (hazard ratio [HR] = 0.74 [95% confidence interval {CI} 0.65-0.85]; p < 0.0001) (absolute risk reduction [ARR] = 4.9% [16.3% vs 21.2% patients with event, respectively]). During the trial, one CV death or hHF or an urgent visit associated with HF could be avoided for every 21 patients treated.

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

Forxiga (known as Farxiga in the US) is approved by the US Food and Drug Administration (FDA), as well as in several other countries around the world, for the for the treatment of patients with HFrEF.

Forxiga is evolving cardiorenal prevention as science continues to identify the underlying links between the heart, kidneys and pancreas. DAPA-HF is part of DapaCare, a robust clinical trial programme to assess the potential CV and renal benefits of Forxiga, including the DECLARE-TIMI 58 trial which first evaluated Forxiga for the treatment of hHF and CV risk factors in patients with T2D. The programme has also explored the treatment of patients with chronic kidney disease (CKD) in the ground-breaking DAPA-CKD Phase III trial and is also currently being tested for HF patients with preserved ejection fraction (HFpEF) in the DELIVER Phase III trial with data anticipated in the second half of 2021.