The FDA approved Vifor Pharma’s Mircera, used to treat anemia in individuals with chronic kidney disease, for use in pediatric patients.
The approval is for patients on hemodialysis, aged 5 to 17, who are converting from another erythropoiesis-stimulating agent (ESA) drug after their hemoglobin level was stabilized with an ESA medication.
The approval was based on data obtained from a multiple dose, multicenter, open-label, dose-finding trial that involved 64 pediatric patients with CKD on hemodialysis and with stable hemoglobin levels. The patients previously received another ESA, either epoetin alfa/beta or darbepoetin alfa.
The safety findings observed in the pediatric patients were consistent with those previously reported in adults.