FDA approves Monoferric for iron deficiency anemia.- Pharmacosmos Therapeutics

Pharmacosmos Therapeutics announced that the FDA has approved Monoferric (ferric derisomaltose) injection 100 mg/mL. Monoferric is an intravenous iron indicated for the treatment of iron deficiency anemia (IDA) in adult patients who have an intolerance to oral iron or have had unsatisfactory response to oral iron, or who have non-hemodialysis dependent chronic kidney disease. The safety and efficacy of Monoferric for treatment of IDA were evaluated in two randomized, open-label clinical trials with active control (FERWON studies) performed in a total of 3050 patients with IDA of different etiologies. Trial 1 (FERWON-IDA) included patients with IDA who had intolerance to oral iron or who had had unsatisfactory response to oral iron or for whom there was a clinical need for rapid repletion of iron stores. Trial 2 (FERWON-NEPHRO) included patients with IDA who had non-dialysis dependent chronic kidney disease. In these two 8-week trials, patients were randomized 2:1 to treatment with Monoferric or iron sucrose. Monoferric was intravenously administered as a single dose of 1000 mg. In Trial 1, 1512 adult patients with IDA caused by different etiologies were randomized in a 2:1 ratio to treatment with Monoferric or iron sucrose. The efficacy of Monoferric was established based upon the change in Hb from baseline to week 8. Non-inferiority was demonstrated for change in Hb from baseline to Week 8. Patients in both arms of this study experienced a mean change in hemoglobin of 2.49 g/dL from baseline to week 8. These increases were statistically significant. Trial 2 enrolled 1538 patients with NDD-CKD. The efficacy of Monoferric was established based upon the demonstration of non-inferiority for change in hemoglobin from baseline to Week 8. Patients receiving Monoferric 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 in hemoglobin from baseline to Week 8 of 1.14 g/dL. Based upon these results, non-inferiority was confirmed. In Trial 1 and Trial 2 combined, adverse reactions were reported in 8.6% of patients treated with Monoferric. The most common adverse reactions reported were nausea (1.2%) and rash (1.0%). Adjudicated serious or severe hypersensitivity reactions were reported in 6/2008 (0.3%) patients in the Monoferric group.