Forxiga (dapagliflozin) gets European green light for heart failure treatment
Forxiga (dapagliflozin) has been approved to help treat symptomatic chronic heart failure (HF) with reduced ejection fraction (HFrEF) in adults.
The decision, made by the European Commission (EC), was based on the positive results from the landmark DAPA-HF Phase III trial, which was published in The New England Journal of Medicine.
This announcement follows the recommendation for approval by the Committee for Medicinal Products for Human Use of the European Medicines Agency.
Today’s approval provides physicians with a completely novel treatment for heart failure with reduced ejection fraction Dr John McMurray
It is thought there are nearly one million people in the UK living with heart failure, with the 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 per cent by the end of April.
Dr John McMurray, Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, 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.”
Dapagliflozin is the first SGLT2 inhibitor to have shown a statistically significant reduction in the risk of cardiovascular (CV) death or worsening of heart failure 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 people with heart failure was consistent with the known safety profile of dapagliflozin.
Tom Keith-Roach, President of AstraZeneca UK, said: “This is exciting news for heart failure patients both with and without type 2 diabetes. With more effective treatments we see the clear opportunity to help eradicate heart failure as one of the UK’s leading causes of hospitalisation and death and we look forward to working with our partners in the NHS to transform standards of care and improve outcomes for these patients.”