European commission approves forxiga (dapagliflozin) for the treatment of symptomatic chronic heart failure with reduced ejection fraction in adults.
Dapagliflozin is the first SGLT2 inhibitor approved in the European Union (EU) for adult patients with symptomatic chronic heart failure with reduced ejection fraction (HFrEF) with and without type 2 diabetes (T2D).
Almost one million people are living with heart failure (HF) in the UK, with associated mortality risk being worse than some of the most common cancers.
Luton, UK, 5 November 2020 – AstraZeneca today announced that the European Commission (EC) has approved a change to the terms of the marketing authorisation for Forxiga
(dapagliflozin) to include the treatment of symptomatic chronic heart failure (HF) with reduced ejection fraction (HFrEF) in adults.1,2 The approval by the EC is based on the positive results from the landmark DAPA-HF Phase III trial, published in The New England Journal of Medicine.5 It follows the recommendation for approval by the Committee for Medicinal Products for Human Use of the European Medicines Agency.
John McMurray, MD, Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, UK, said: “Today’s approval provides physicians with a completely novel treatment for heart failure with reduced ejection fraction, not only improving symptoms and reducing hospital admissions, but also increasing survival in this life-threatening condition.”
HF is a life-threatening, chronic condition where a person’s heart is unable pump enough blood to their organs.6 Almost one million people are living with HF in the UK, with HF mortality risk being worse than some of the most common cancers. The COVID-19 pandemic has also had a significant impact on heart failure treatment services, with recent data showing that the number of people presenting to hospitals with heart failure had dropped by 66% by the end of April.7 Dapagliflozin 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. The overall safety profile of dapagliflozin in patients with heart failure was consistent with the known safety profile of dapagliflozin.
Pumping Marvellous Foundation Comment by Nick Hartshorne-Evans Founder and CEO
This is a real step in the right direction and we welcome the decision following the recommendation for approval by the Committee for Medicinal Products for Human Use of the European Medicines Agency. Hot on the heels of Entresto, AstraZeneca brings out the first SGLT2 inhibitor that demonstrates significant benefit to people diagnosed with heart failure with or without type 2 diabetes. Significantly the size of the patient population with heart failure with a reduced ejection fraction without type 2 diabetes is significant. This is one of those moments which we will look back on and view as a shift in progressive treatments for people living with heart failure with reduced ejection fraction.