Rare Disease Report

FDA Approves Mircera for Pediatric Anemia Associated with Chronic Kidney Disease

JUNE 13, 2018
Krista Rossi
The US Food and Drug Administration (FDA) recently approved methoxy polyethylene glycol-epoetin beta (Mircera) for the treatment of anemia associated with chronic kidney disease (CKD) in pediatric patients between 5 and 17 years of age on dialysis.

Methoxy polyethylene glycol-epoetin beta is an epoetin alfa/beta or darbepoetin alfa (ESA) and is formulated as a sterile, preservative-free protein solution for intravenous or subcutaneous administration.

Data from an open-label, multiple-dose, multicenter, dose-finding trial (NCT00717366) in 64 pediatric patients (ages 5 to 17 years) with CKD on hemodialysis who had stable hemoglobin (Hb) levels while previously receiving another ESA served as the basis for the approval.

Participating subjects received methoxy polyethylene glycol-epoetin beta intravenously once every 4 weeks for 20 weeks. Dosage adjustments were permitted to maintain target Hb levels following the first administration.

Efficacy of the treatment was based on maintaining Hb levels within target levels in the clinical trial and also from extrapolation from trials of methoxy polyethylene glycol-epoetin beta in adult patients with CKD, according to the US Food and Drug Administration. Safety data pertaining to pediatric patients proved to be consistent with data that had previously been reported in adults who received the treatment.

Methoxy polyethylene glycol-epoetin beta is administered once every 4 weeks based on total weekly epoetin alfa or darbepoetin alfa dose at the time of conversion per conversion from another ESA.
 

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