American Regent and Daiichi Sankyo have announced that the INJECTAFER (ferric carboxymaltose injection) has received approval from the US Food and Drug Administration (FDA) to treat iron deficiency in adult patients with heart failure.
The therapy is indicated to improve exercise capacity in heart failure patients, who are categorised as New York Heart Association class II/III based on the severity of their symptoms.
American Regent chief medical officer Ravi Tayi stated: “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 anaemia, which can affect their daily lives and activities.
“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 paediatric patients with iron deficiency anaemia, and now for adult patients with heart failure who have iron deficiency.”
The regulatory approval was based on findings obtained from a randomised controlled trial called CONFIRM-HF.
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The trial was designed for assessing the safety and efficacy of INJECTAFER in chronic heart failure and iron deficiency adult patients.
The findings showed that the INJECTAFER treatment significantly improved exercise capacity in the patients compared to placebo.
Hypertension, hypophosphatemia, nausea, dizziness, headache and injection site reactions are the most common adverse reactions observed with the therapy.
INJECTAFER was previously approved to treat iron deficiency anaemia (IDA) in adult and paediatric patients aged one year and above who show intolerance or an unsatisfactory response to oral iron.
It is also indicated for IDA adult patients with non-dialysis-dependent chronic kidney disease.