The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use in December 2022 and was based on the positive results from the DELIVER Phase III trial. Results from the prespecified pooled analysis of DELIVER and DAPA-HF Phase III trials also established dapagliflozin as the first HF medication to demonstrate mortality benefit across the full ejection fraction range.

HF is a chronic, long-term condition that worsens over time and affects about 15 million people in Europe. Approximately half of HF patients die within five years of diagnosis, and patients with HFmrEF and HFpEF are not only at greater risk of death and hospitalisations but experience an especially high burden of symptoms and physical limitations, and a poor quality of life.

HFmrEF and HFpEF are also severely underdiagnosed as signs and symptoms are often nonspecific and overlapping with other clinical conditions. Dapagliflozin is approved for the treatment of patients with type-2 diabetes (T2D), HFrEF and CKD in more than 100 countries around the world including the US, the EU, China and Japan. It has most recently received regulatory approvals in Great Britain, Japan and Turkey to extend the HF indication to include patients across the full spectrum of LVEF. The HF indication extension application is currently under review in the US and other countries.