American Regent’s HEART-FID trial for INJECTAFER fails to meet primary endpoint

American Regent, Inc., a subsidiary of Daiichi Sankyo Group, has announced disappointing results from its phase 3 HEART-FID trial of INJECTAFER (ferric carboxymaltose injection) for the treatment of iron deficiency in adult heart failure patients with reduced ejection fraction (HFrEF). Despite a numerical improvement in certain outcomes, the study failed to achieve statistical significance for its primary endpoint. These results may cast a shadow over INJECTAFER’s efficacy in treating subsets of heart failure patients.

Lack of Statistical Significance: A Closer Look at the HEART-FID Data

The HEART-FID trial was uniquely designed as a single pivotal study rather than two, in accordance with a special protocol assessment with the U.S. Food and Drug Administration (FDA). The study focused on a hierarchical composite of death and heart failure hospitalization at 12 months, as well as changes in the 6-minute walk test distance from baseline to 6 months. Although the study revealed numerically fewer deaths and heart failure hospitalizations in the group treated with INJECTAFER compared to the placebo group, it did not meet the pre-specified significance level of 0.0099.

Results Discussed at European Society of Cardiology Congress 2023

Data from the failed HEART-FID study were presented in a late-breaking research Hot Line session at the European Society of Cardiology Congress 2023 and simultaneously published in the New England Journal of Medicine. These findings were expected to deepen the understanding of IV iron treatment with ferric carboxymaltose in subsets of patients with heart failure, according to Ravi Tayi, MD, MPH, Chief Medical Officer of American Regent, Inc.

INJECTAFER: A Previously Extensively Studied Intravenous Iron Treatment

INJECTAFER is already extensively studied and approved for treating iron deficiency anemia in adult and pediatric patients, as well as for certain adult patients with heart failure. However, the HEART-FID trial, which is the first of its kind to focus on a composite endpoint of death and heart failure hospitalization, raises questions about the medication’s effectiveness for a wider range of heart failure patients.

INJECTAFER is manufactured and marketed under the name Ferinject by CSL Vifor outside of North America.