FDA New Drug Application and Priority Review for SGLT2i for HF across the full spectrum of ejection fraction

News - Nov. 23, 2021

The FDA has accepted a supplemental New Drug Application and granted Priority Review for the SGLT2 inhibitor empagliflozin for the treatment of adults with heart failure (HF) across the full spectrum of left ventricular ejection fraction (LVEF) to reduce risk of CV death or HF hospitalization.

This is based on results from the EMPEROR-Preserved trial , a phase III international, randomized, double-blind trial that enrolled 5,998 patients with and without T2DM. All patients had HF and LVEF >40%. In this trial, empagliflozin reduced the composite primary endpoint of CV death or HF hospitalization by 21% compared with placebo after a median follow-up of 26.2 months.

A Priority Review designation has the intention to direct attention and resources to the evaluation of applications for a treatment that, if approved, would be an improvement in the safety or effectiveness of treatments for serious conditions. Earlier this year, the FDA granted Breakthrough Therapy designation to empagliflozin as treatment for patients with HFpEF.

Empagliflozin is currently indicated for patients with HFrEF to reduce risk of CV death or HF hospitalization.

Source: press release November 11, 2021

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