Tag Archives: European Union

The EU approval is based on positive results from the landmark DAPA-HF phase III trial, published in The New England Journal of Medicine (DOI: 10.1056/NEJMoa1911303) and follows the recommendation for approval by the Committee for Medicinal Products for Human Use of the European Medicines Agency. Dapagliflozin is the first SGLT2 inhibitor to have shown a statistically significant reduction in the risk of the composite of cardiovascular death or worsening of heart failure events, including hospitalisation for HF.