FDA Approves Ferric Carboxymaltose Injection for Iron Deficiency in Heart Failure

US Food and Drug Administration (FDA)

Today, the US Food and Drug Administration (FDA) approved ferric carboxymaltose injection (INJECTAFER®) for the treatment of iron deficiency in adult patients with heart failure, marking the first and only intravenous iron replacement therapy for this indication.¹

Announced in a release by Daiichi Sankyo, Inc. and American Regent, Inc., the treatment improves exercise capacity in patients with heart failure categorized as New York Heart Association (NYHA) class II/III, based on the severity of their symptoms. Those with a slight or distinct limitation in their physical activity due to fatigue, palpitation, and/or dyspnea are considered to have NYHA class II/III heart failure.

“This new indication for INJECTAFER marks the first and only FDA approval of an intravenous iron replacement therapy for adult patients with heart failure, a progressive and chronic disease. Approximately 2.8 million US adults are impacted by heart failure with iron deficiency or iron deficiency anemia, which can affect their daily lives and activities,” said Ravi Tayi, MD, MPH, chief medical officer at American Regent, Inc. “INJECTAFER is the most extensively studied intravenous iron and the latest approval continues to build on the effect and proven use of INJECTAFER for adult and pediatric patients with iron deficiency anemia, and now for adult patients with heart failure who have iron deficiency.”

Ferric carboxymaltose injection has been previously indicated for iron deficiency anemia (IDA) in adult and pediatric patients 1 year of age and older who have either intolerance to oral iron or an unsatisfactory response to oral iron and adult patients with non-dialysis-dependent chronic kidney disease.² The therapy is provided intravenously in 2 doses of 750 mg each ≥7 days apart for patients weighing ≥50 kg (110lbs); for those weighing <50kg, each of the 2 doses is administered as 15 mg/kg body weight separated by ≥7 days.

Dosing regimens for iron deficiency in adult patients with heart failure and NYHA class II/III is based on patient weight (154.3lbs) and hemoglobin level (<10 to 14-15 grams per deciliter [g/dl]), starting at a single 500 mg dose up to two 1000 mg doses separated by 6 weeks. In addition, a maintenance dose of 500 mg may be provided at 12, 24, and 36 weeks for patients based on serum ferritin levels and transferrin saturation value.

The newest approval was supported by data from the randomized, controlled CONFIRM-HF trial that evaluated the efficacy and safety of ferric carboxymaltose injection in adult patients with chronic heart failure and iron deficiency. Results from CONFIRM-HF showed the therapy significantly improved exercise capacity compared to placebo in iron-deficient patients with heart failure. Safety results from CONFIRM-HF were generally consistent with the known safety profile of ferric carboxymaltose injection, according to the release.

Safety was evaluated in adult patients with iron deficiency and heart failure in the randomized controlled FAIR-HF and AFFIRM-AHF trials, as well as the CONFIRM-HF trial. The trials included 1016 patients who received ferric carboxymaltose injection and 857 patients who received placebo. The overall safety profile was consistent across the studied indications, with the most common treatment-emergent adverse events including headache, nausea, hypertension, injection site reactions, hypophosphatemia, and dizziness.

More than 40 clinical trials with over 8,800 patients worldwide have studied ferric carboxymaltose injection, with the therapy having been approved in 86 countries since its initial European Union approval in 2007.

References

1. Injectafer® approved in the U.S. for the treatment of iron deficiency in adult patients with heart failure. Business Wire. June 5, 2023. Accessed June 5, 2023. https://www.businesswire.com/news/home/20230605005213/en/INJECTAFER%C2%AE-Approved-in-the-U.S.-for-the-Treatment-of-Iron-Deficiency-in-Adult-Patients-with-Heart-Failure.
2. Iapoce C. FDA approves single dose ferric Carboxymaltose Injection treatment. HCPLive. May 14, 2021. Accessed June 5, 2023. https://www.hcplive.com/view/fda-approves-single-dose-ferric-carboxymaltose-injection-treatment.