FDA approves pediatric use of Mircera

The US Food and Drug Administration has approved Mircera (methoxy polyethylene glycol-epoetin beta) (for the treatment of pediatric patients 5 to 17 years of age on hemodialysis who are converting from another ESA after their hemoglobin level was stabilized with an ESA.

Swiss firm Vifor Pharma (VTX: VIFN) holds marketing rights to Mircera in the USA from Swiss drug giant Roche (ROG: SIX). The drug is distributed in the USA by joint venture Vifor Fresenius Medical Care Renal Pharma through the Fresenius Kidney Care clinics.

Approval was based on 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 and had stable hemoglobin (Hb) levels while previously receiving another ESA (epoetin alfa/beta or darbepoetin alfa). Patients were administered Mircera intravenously once every four weeks for 20 weeks. After the first administration of Mircera, dosage adjustments were permitted to maintain target Hb levels.