European Commission approves SGLT2i in chronic HF regardless of ejection fractionNews - Mar. 8, 2022
The European Commission has granted marketing authorization for empagliflozin for the treatment of symptomatic chronic HF across the full spectrum of LVEF. Empagliflozin was previously approved by the European Commission for the treatment of adults with symptomatic chronic HFrEF. The new approval expands the existing indication of empagliflozin to include adults with symptomatic chronic HFpEF.
This approval from the European Commission follows the approval from the FDA, which was received on 24 February 2022.
The approval is based on the results from the EMPEROR-Preserved phase III trial, which demonstrated that empagliflozin significantly reduced the primary composite endpoint of CV death or HF hospitalization by 21% in patients with HF and EF >40%, with and without diabetes.