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FDA approves Mircera for treatment of anemia in pediatric patients on hemodialysis
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The FDA approved Mircera for the treatment of pediatric patients 5 to 17 years of age on hemodialysis who are converting from another erythropoiesis-stimulating agent after their hemoglobin level was stabilized with an ESA.
According to a release from the FDA, approval was based on data from an open-label, multiple-dose, multicenter, dose-finding trial of 64 pediatric patients with chronic kidney disease on hemodialysis. Patients had stable hemoglobin (Hb) levels while previously receiving another ESA. They were administered Mircera (Vifor Pharma Inc.) intravenously once every 4 weeks for 20 weeks. After the first administration, dosage adjustments were permitted to maintain target Hb levels.
Efficacy was based on maintaining Hb levels within target levels in the clinical trial and from extrapolation from trials of Mircera in adults with CKD. The safety findings for pediatric patients were similar to those previously reported for adults, according to the release.
Reference:
www.fda.gov/drugs/informationondrugs/approveddrugs/ucm610210.htm