FDA Approves First Intravenous Iron Replacement Therapy for Adults With Heart Failure, Iron Deficiency


Treatment with Injectafer significantly improved exercise capacity compared to placebo in a randomized clinical trial in adult patients with heart failure.

The FDA has approved ferric carboxymaltose injection (Injectafer; Daiichi Sankyo Inc. and American Regent Inc.) for the treatment of iron deficiency in adult patients with heart failure categorized as New York Heart Association (NYHA) class 2/3 to improve exercise capacity.

The NYHA Functional Classification evaluates patients’ heart failure based on the severity of their symptoms. Patients who have a slight or marked limitation of physical activity due to fatigue, palpitation, or dyspnea are considered to have class 2 or class 3 heart failure, respectively. The new indication marks the first and only FDA approval for an intravenous (IV) iron replacement therapy for this indication.

“This new indication for Injectafer marks the first and only FDA approval of an [IV] iron replacement therapy for adult patients with heart failure, a progressive and chronic disease,” said Ravi Tayi, MD, MPH, chief medical officer at American Regent, Inc., in a press release. “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.”

Ferric carboxymaltose injection now has multiple indications, including for the treatment of iron deficiency in adults with heart failure; iron deficiency anemia (IDA) in adult and pediatric patients 1 year of age and older who are intolerant to oral iron or have an unsatisfactory response; and adults with IDA who have non-dialysis dependent chronic kidney disease. For patients weighing 50 kg or more, it is administered via IV by a health care provider in 2 doses of 750 mg each at least 7 days apart. For patients weighing less than 50 kg, each of the 2 doses is administered as 15 mg/kg body weight separated by at least 7 days.

Dosing for iron deficiency in adults with heart failure and NYHA class 2/3 is based on weight and hemoglobin level, starting at a single 500 mg dose and going up to a pair of 1000 mg doses separated by 6 weeks. A maintenance dose of 500 mg may be administered at 12, 24, and 36 weeks for certain patients based on their serum ferritin levels and transferring saturation value.

The approval was supported by data from the CONFIRM-HF trial evaluating the efficacy and safety of ferric carboxymaltose injection in adult patients with chronic heart failure and iron deficiency. Treatment with Injectafer significantly improved exercise capacity compared to placebo in iron deficient patients with heart failure.

The safety results from the trial were generally consistent with the known safety profile of Injectafer. The most common treatment-emergent adverse events observed with Injectafer were headache, nausea, hypertension, injection site reactions, hypophosphatemia, and dizziness.

“Injectafer is the most extensively studied intravenous iron and this latest approval continues to build on the effective 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,” Tayi said in the press release.

Injectafer has been studied in more than 40 clinical trials that included more than 8800 patients worldwide. It has been approved in 86 countries since the initial European Union approval in 2007.


Injectafer Approved in the US for the Treatment of Iron Deficiency in Adult Patients with Heart Failure. News release. 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

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