Thepatients aged 5-17 years with chronic kidney disease whose hemoglobin had been stabilized with an erythropoiesis-stimulating agent (ESA).
Efficacy was based partly on how well target hemoglobin levels were maintained in this trial, but also on extrapolation from results of trials in adults. The safety profile in these pediatric patients was consistent with those previously observed in adults. Mircera is manufactured by Vifor Pharma.
More information on the approval of Mircera in this population can be found in the FDA. The for Mircera, initially approved in 2007, has also been updated.