Daiichi Sankyo, Inc. and American Regent, Inc., a Daiichi Sankyo Group company, announced that the U.S. Food and Drug Administration (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. Approximately 2.8 million U.S. adults are impacted by heart failure with iron deficiency or iron deficiency anemia, which can affect their daily lives and activities,” said Ravi Tayi, MD, MPH, Chief Medical Officer at American Regent, Inc. “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 New York Heart Association Functional Classification classifies patients’ heart failure based on the severity of their symptoms. Patients who have a slight or marked limitation of their physical activity due to fatigue, palpitation and/or dyspnea are considered to have class II or class III heart failure, respectively.
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.13 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.
INJECTAFER has been studied in more than 40 clinical trials that included over 8,800 patients worldwide. INJECTAFER has been approved in 86 countries since initial European Union approval in 2007 and is the most extensively studied IV iron.
Daiichi Sankyo is committed to ensuring that patients in the U.S. who are prescribed INJECTAFER can access the medication and receive necessary financial support.