FDA approves Injectafer to treat iron deficiency and heart failure – Daiichi Sankyo + American Regent Inc

Daiichi Sankyo, Inc. and American Regent, Inc., a Daiichi Sankyo Group company, announced that the FDA approved Injectafer (ferric carboxymaltose injection) for the treatment of iron deficiency in adult patients with heart failure categorized as New York Heart Association class II/III to improve exercise capacity.

“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. “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.”

The approval was supported by Injectafer data from a randomized controlled study, CONFIRM-HF (NCT01453608), that evaluated the efficacy and safety of Injectafer 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 (TEAEs) observed with Injectafer were headache, nausea, hypertension, injection site reactions, hypophosphatemia, and dizziness.