Mircera Approved to Treat Anemia in Pediatric Patients With CKD

Mircera is an erythropoietin receptor activator.
Mircera is an erythropoietin receptor activator.

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.

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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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