FDA Approves Mircera for Use in Pediatric Patients

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.