AstraZeneca’s sodium-glucose co-transporter-2 (SGLT2 inhibitor) dapagliflozin has been approved in the European Union (EU) for the treatment of symptomatic chronic heart failure with reduced ejection fraction in adults with and without type 2 diabetes.
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.
