fda update

On June 7, 2018, the U.S. Food and Drug Administration approved methoxy polyethylene glycol-epoetin beta (Mircera®, Vifor Pharma Inc.) for the treatment of pediatric patients aged 5–17 years on hemodialysis who are converting from another erythropoiesis-stimulating agent (ESA) after their hemoglobin level was stabilized with an ESA.

Approval was based on data from an open-label, multiple dose, multicenter, dose-finding trial (NCT00717366) in 64 pediatric patients (aged 5–17 years) with chronic kidney disease (CKD) on hemodialysis and had stable hemoglobin (Hb) levels while previously receiving another ESA (epoetin alfa/beta or darbepoetin alfa). Patients were administered methoxy polyethylene glycol-epoetin beta via IV once every 4 weeks for 20 weeks. After the first administration, dosage adjustments were permitted to maintain target Hb levels.

Efficacy was based on maintaining Hb levels within target levels during the clinical trial, and also from extrapolation from trials of methoxy polyethylene glycol-epoetin beta in adult patients with CKD. The safety findings observed in pediatric patients were consistent with those previously reported in adults.

For conversion from another ESA, methoxy polyethylene glycol-epoetin beta is dosed via IV once every four weeks based on total weekly epoetin alfa or darbepoetin alfa dose at time of conversion. Full prescribing information is available at Mircera PI.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 800-FDA-1088.