Forxiga approved in the EU for the treatment of symptomatic chronic heart failure

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 Forxiga 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. These conditions are frequently complicated by multiple interrelated diseases, specifically coronary heart disease, obesity, diabetes, long-standing hypertension, and chronic kidney disease (CKD), highlighting the importance of risk management for patients with this complex syndrome.