The Food and Drug Administration (FDA) has approved Injectafer® (ferric carboxymaltose injection) for the treatment of iron deficiency in adult patients with heart failure (HF) categorized as New York Heart Association (NYHA) class II/III to improve exercise capacity.
The approval was based on data from the randomized, double-blind, placebo-controlled phase 4 CONFIRM-HF trial (ClinicalTrials.gov Identifier: NCT01453608), which evaluated the efficacy and safety of Injectafer in adults with iron deficiency and chronic HF with left ventricular ejection fraction of less than 45% and NYHA class II/III. Patients were randomly assigned to receive either a single dose intravenously of Injectafer or placebo on day 0. The primary endpoint was the change from baseline to week 24 in 6-minute walk distance (6MWD).
The mean change in 6MWD from baseline to week 24 in Injectafer-treated patients was reported to be 18 meters (95% CI, 4-32) compared with -7 meters (95% CI, -21, 7) in the placebo group (treatment difference, 25 meters; [95% CI, 7-43]; P =.007). Among patients treated with Injectafer, the change from baseline to week 24 in serum ferritin, transferrin saturation, and hemoglobin was 269ng/mL, 9%, and 0.6g/dL, respectively. The most common treatment emergent adverse events were headache, nausea, hypertension, injection site reactions, hypophosphatemia, and dizziness.
“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,” 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.”
Injectafer is supplied as 2mL, 15mL, and 20mL single-dose vials containing 50mg/mL of iron as ferric carboxymaltose.
- Injectafer® approved in the US for the treatment of iron deficiency in adult patients with heart failure. News release. Daiichi Sankyo and American Regent. Accessed June 5, 2023. https://www.businesswire.com/news/home/20230605005213/en/INJECTAFER%C2%AE-Approved-in-the-U.S.-for-the-Treatment-of-Iron-Deficiency-in-Adult-Patients-with-Heart-Failure.
- Package insert. American Regent, Inc.; 2023. Accessed June 5, 2023. https://daiichisankyo.us/prescribing-information-portlet/getDocument?product=IF&inline=true.