FDA Grants First HF Indication for IV Iron to Ferric Carboxymaltose

7 Jun 2023 • Ferric carboxymaltose has become the first form of intravenous iron replacement to earn a US Food and Drug Administration indication for heart failure. Injectafer is already approved for iron deficiency anemia in adult patients intolerant or resistant to oral iron, or who have non-dialysis-dependent chronic kidney disease. The new indication, to improve exercise capacity, includes iron deficiency in adult patients with New York Heart Association class II/III heart failure.

In all, this injectable formulation has been studied in 40 clinical trials and over 8,800 patients, making it the “most extensively studied IV iron,” a press release states. International guidelines already recommend screening for iron deficiency in heart failure and support intravenous iron repletion: the most recent European Society of Cardiology heart failure guidelines specify that intravenous ferric carboxymaltose can be considered to prevent further heart failure admissions in symptomatic patients recently hospitalized.

This new indication for Injectafer marks the first and only FDA approval of an intravenous iron replacement therapy for adult patients with heart failure,” Chief Medical Officer Ravi Tayi, MD, MPH, is quoted in the press release. “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.”

Source: tctMD | Read full story

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