The Food and Drug Administration (FDA) has approved Mircera (methoxy polyethylene glycol-epoetin beta; Vifor) for the treatment of anemia associated with chronic kidney disease (CKD) in pediatric patients 5–17 years of age on hemodialysis who are converting from another erythropoiesis-stimulating agent (ESA) after their hemoglobin level was stabilized with an ESA. Mircera is also indicated to treat CKD-associated anemia in adult patients.
The approval was based on an open-label, multiple dose, multicenter, dose-finding study in 64 pediatric patients with CKD who were on hemodialysis and who had stable hemoglobin levels while previously receiving another ESA. Patients who received Mircera (at a dose calculated using the recommended conversion factor) had a mean change in hemoglobin concentration from baseline of -0.15g/dL (95% CI -0.49, 0.2). Supportive efficacy results in the Mircera-treated arm showed that 75% of patients maintained hemoglobin values within ± 1g/dL of baseline and 81% maintained hemoglobin values within 10–12g/dL during the evaluation period.
Mircera is an erythropoietin receptor activator with greater activity in vivo as well as increased half-life, in contrast to erythropoietin. It is formulated as a sterile, preservative-free protein solution for intravenous (adult and pediatric) or subcutaneous (adult only) administration and is supplied in single-dose prefilled syringes (30mcg/0.3mL, 50mcg/0.3mL, 75mcg/0.3mL, 100mcg/0.3mL, 120mcg/0.3mL, 150mcg/0.3mL, 200mcg/0.3mL, 250mcg/0.3mL, 360mcg/0.6mL).
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