FDA approves SGLT2i for treatment of HF across full spectrum of LVEF
The FDA has approved the use of the SGLT2 inhibitor dapagliflozin to reduce the risk for CV death, HF hospitalization and urgent HF visits in adults across the full spectrum of LVEF. Previously, dapagliflozin was only approved in the US for adults with HFrEF.
The decision by the FDA was based on the results from the phase 3 DELIVER trial. In DELIVER, dapagliflozin reduced the primary composite endpoint of CV death or worsening HF in patients with HFmrEF or HFpEF. In a pre-specified, pooled analysis of the phase 3 DAPA-HF and DELIVER trials, it was demonstrated that dapagliflozin reduced the composite endpoint of CV death, HF hospitalization or urgent HF visits in patients with HF across the full range of LVEF.
Dapagliflozin is approved for the treatment of patients with T2DM, HFrEF and CKD in more than 100 countries in the world, including US, EU, China and Japan. Earlier this year, the use of dapagliflozin was already extended to include patients across the full LVEF range in the EU.