Intravenous Iron Receives FDA Approval for Adults with Iron Deficiency Anemia
Iron deficiency anemia is a condition that affects nearly 1 billion people globally,1 in which the blood lacks adequate healthy red blood cells, often leaving those with the condition tired and short of breath.2
The FDA has approved ferric derisomaltose injection 100 mg/mL (Monoferric, Pharmacosmos Therapeutics Inc) for adults with iron deficiency anemia who have an intolerance to or have had an unsatisfactory response to oral iron, or who have non-hemodialysis dependent chronic kidney disease (CKD).1
Iron deficiency anemia is a condition that affects nearly 1 billion people globally,1 in which the blood lacks adequate healthy red blood cells, often leaving those with the condition tired and short of breath.2 Although it can usually be corrected with iron supplementation, some may not respond adequately to typical oral supplements.2
The safety and efficacy of ferric derisomaltose was established in 2 randomized, open-label clinical trials with active control, performed in a total of 3050 patients.
In trial 1, 1512 adult patients with iron deficiency anemia were randomized 2:1 to treatment with ferric derisomaltose or iron sucrose. The efficacy and non-inferiority of ferric derisomaltose were both demonstrated in the change in hemoglobin from baseline to week 8. Patients in both arms experienced a mean change in hemoglobin of 2.49 g/dL during those 8 weeks.
Trial 2 enrolled 1538 patients with non-dialysis-dependent CKD. In this study, patients receiving ferric derisomaltose experienced a mean increase in hemoglobin from baseline to week 8 of 1.22 g/dL, and patients treated with iron sucrose experienced a mean increase of 1.14 g/dL during the same period.
Across the 2 trials combined, 8.6% of patients treated with ferric derisomaltose reported adverse reactions, the most common of which were nausea (1.2%) and rash (1.0%). Adjudicated or severe hypersensitivity reactions were reported in 0.3% of patients in the ferric derisomaltose group.
- Monoferric (ferric derisomaltose) injection is approved by the US FDA for the treatment of iron deficiency anemia [news release]. Holbaek, Denmark; Jan 29, 2020. Pharmacosmos.com/news-media/news/2020/monoferric-ferric-derisomaltose-injection-is-approved-in-the-us. Accessed Jan 29, 2020.
- Iron Deficiency Anemia. Mayo Clinic, updated Oct. 18, 2019. Mayoclinic.org/diseases-conditions/iron-deficiency-anemia/symptoms-causes/syc-20355034. Accessed Jan 29, 2020.