BASKING RIDGE, N.J. & SHIRLEY, N.Y.– Daiichi Sankyo, Inc. and American Regent, Inc., a Daiichi Sankyo Group company, today 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.1
“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,”1-10 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.”11
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.12
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.14
INJECTAFER has been studied in more than 40 clinical trials that included over 8,800 patients worldwide.15 INJECTAFER has been approved in 86 countries since initial European Union approval in 2007 and is the most extensively studied IV iron.11,16
1 Injectafer [package insert]. Shirley, NY: American Regent, Inc.; May 2023.
2 MonoFerric [package insert]. Morristown, NJ: Pharmacosmos Therapeutics Inc.; February 2022.
3 Venofer [package insert]. Shirly, NY: American Regent, Inc.; October 2020.
4 INFeD [package insert]. Madison, NJ: Allergan; September 2021.
5 Ferrlecit [package insert]. Bridgewater, NJ: sanofi-aventis US LLC; March 2021.
6 Feraheme [package insert]. Waltham, MA: AMAG Pharmaceuticals, Inc.; June 2022.
7 Virani S, Alonso A, Aparicio H, et al. Heart Disease and Stroke Statistics – 2020 Update. Circulation. 2020; 141(9): e139-e596.
8 Ebner N, von Haehling S. Why is iron deficiency recognised as an important comorbidity in heart failure? Card Fail Rev. 2019;5(3):173-5.
9 Anand IS, Gupta P. Anemia and Iron Deficiency in Heart Failure: Current Concepts and Emerging Therapies. Circulation. 2018 Jul 3;138(1):80-98.
10 Data on file. Injectafer Heart Failure Demand Assessment in the Outpatient Setting Working Meeting; March 2022.
11 Data on file. Injectafer Studies. Daiichi Sankyo Inc., Basking Ridge, NJ.
12 Classes of Heart Failure. American Heart Association. May 2017. https://www.heart.org/en/health-topics/heart-failure/what-is-heart-failure/classes-of-heart-failure
13 Ponikowski P, van Veldhuisen DJ, Comin-Colet J, et al. Beneficial effects of long-term intravenous iron therapy with ferric carboxymaltose in patients with symptomatic heart failure and iron deficiency. Eur Heart J. 2015 Mar 14;36(11):657-68.
14Data on file. Module 5 (Integrated Summary of Safety for FCM). Daiichi Sankyo Inc., Basking Ridge, NJ.
15Data on file. PSUR (Periodic Safety Update Report), January 2017. Luitpold Pharmaceuticals, Inc., Shirley, NY.
16 Vifor Pharma Annual Report. https://www.viforpharma.com/investors/annual-report-2020. Accessed February 2023.
