The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application for empagliflozin to reduce the risk of cardiovascular (CV) death plus hospitalization for heart failure (HF) in adults with HF independent of left ventricular ejection fraction (LVEF).
The application is supported by data from the randomized, double-blind, phase 3 EMPEROR-Preserved trial (ClinicalTrials.gov Identifier: NCT03057951), which compared the efficacy and safety of empagliflozin with placebo in 5988 adults with HF with preserved ejection fraction, with and without diabetes. Patients were randomly assigned 1:1 to receive either empagliflozin 10mg once daily (n=2997) or placebo (n=2991), in addition to standard of care for up to 38 months.
Results from the trial showed that treatment with empagliflozin met the primary composite endpoint with a 21% relative risk reduction (3.3% absolute risk reduction) for CV death or hospitalization for HF in adults with HF with LVEF over 40%; these results were independent of ejection fraction or diabetes status.
Additionally, a recent prespecified sub-analysis of the EMPEROR-Preserved trial showed that treatment with empagliflozin reduced the risk of CV death or hospitalization for HF and slowed kidney function decline in adults with HF and LVEF over 40% regardless of chronic kidney disease (CKD) status.
Empagliflozin is marketed under the brand name Jardiance. In August 2021, the FDA approved Jardiance to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with chronic heart failure with reduced ejection fraction.
The approval was based on data from the phase 3 EMPEROR-Reduced trial (ClinicalTrials.gov Identifier: NCT03057977), which demonstrated that treatment with empagliflozin reduced the combined relative risk of CV death or hospitalization for HF by 25% compared with placebo in adults with HF with reduced ejection fraction.
“Building on the recent FDA approval of Jardiance for heart failure with reduced ejection fraction, this supplemental New Drug Application acceptance is a step toward the potential to make Jardiance the sole treatment to demonstrate a statistically significant benefit for adults across the full spectrum of heart failure regardless of ejection fraction,” said Mohamed Eid, MD, MPH, MHA, vice president, Clinical Development & Medical Affairs, Cardio-Metabolism & Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals, Inc. “The FDA’s Priority Review designation further reinforces the urgent need for additional treatments for heart failure.”
US FDA accepts supplemental New Drug Application and grants Priority Review for Jardiance® for adults with heart failure independent of left ventricular ejection fraction. News release. Boehringer Ingelheim and Eli Lilly and Company. Accessed November 11, 2021. https://www.prnewswire.com/news-releases/us-fda-accepts-supplemental-new-drug-application-and-grants-priority-review-for-jardiance-for-adults-with-heart-failure-independent-of-left-ventricular-ejection-fraction-301422472.html.