FDA Breakthrough Therapy Designation for SGLT2i in HFpEF
The SGLT2 inhibitor empagliflozin received Breakthrough Therapy Designation by the US Food and Drug Administration (FDA) as an investigational treatment for patients with heart failure with preserved ejection fraction (HFpEF). This decision is based on the results of the EMPEROR-Preserved trial .
Breakthrough designation is given to treatments of serious or life-threatening conditions and preliminary findings indicate that the drug may provide substantial improvement on clinically significant endpoints compared to existing therapies.
Empagliflozin is approved for the treatment of patients with type 2 diabetes and for the treatment of patients with heart failure with reduced ejection fraction (HFrEF) with or without diabetes, in the EU and the US.