The US Food and Drug Administration (FDA) has expanded the indication for ferric carboxymaltose injection (Injectafer, Daiichi Sankyo/American Regent) to include treatment of iron deficiency in adults with New York Heart Association (NYHA) class II/III heart failure (HF).
"This new indication for Injectafer marks the first and only FDA approval of an intravenous iron replacement therapy for adult patients with heart failure," Ravi Tayi, MD, MPH, chief medical officer at American Regent, said in a news release.
Ferric carboxymaltose injection is also indicated for the treatment of iron deficiency anemia in adults and children as young as 1 year of age who have either intolerance or an unsatisfactory response to oral iron, and in adult patients who have nondialysis dependent chronic kidney disease.
The new indication in HF was supported by data from the CONFIRM-HF randomized controlled trial that evaluated the efficacy and safety of ferric carboxymaltose injection in adults with chronic HF and iron deficiency.
In the study, results showed that treatment with ferric carboxymaltose injection significantly improved exercise capacity compared with placebo in iron-deficient patients with HF.
No new safety signals emerged. The most common treatment emergent adverse events were headache, nausea, hypertension, injection site reactions, hypophosphatemia, and dizziness.
According to the company, ferric carboxymaltose injection has been studied in more than 40 clinical trials that included over 8800 patients worldwide and has been approved in 86 countries.
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