Intravenous Iron Receives FDA Approval for Adults with Iron Deficiency Anemia

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.

REFERENCES

• 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.