The SGLT2 inhibitor Dapagliflozin (Farxiga, AstraZeneca) has been approved by the US Food and Drug Administration (FDA) for the treatment of heart failure (HF) across the entire left-ventricular ejection fraction (LVEF) spectrum, which includes HF with preserved ejection fraction (HFpEF) and HF with mildly reduced ejection fraction (HFmrEF).

The sodium-glucose cotransporter 2 (SGLT2) inhibitor was formerly licensed in the United States for individuals with heart failure with decreased ejection fraction (HFrEF). It is also authorized for use in individuals with chronic renal disease. In 2014 it was approved to enhance glycemic control in people with type 2 diabetes.

The new indication is based on findings from the phase 3 DELIVER study, which demonstrated strong clinical advantages of the SGLT2 inhibitor for patients with HF independent of left-ventricular function.

Dapagliflozin showed a statistically significant and clinically relevant early decrease in the primary composite endpoint of cardiovascular (CV) mortality or worsening HF for individuals with HFmrEF or HFpEFF in the trial including over 6200 participants.

Furthermore, a pooled analysis of the DAPA-HF and DELIVER phase 3 studies found that Dapagliflozin therapy consistently reduced the combined endpoint of CV mortality or HF hospitalization across the LVEF range.

In February, the European Commission amended the prescription for Dapagliflozin (Forxiga) to cover HF throughout the complete spectrum of LVEF.

(Source: https://www.medscape.com/viewarticle/991736?src=)