FDA Expands Indication of Anemia Drug

The US Food and Drug Administration (FDA) has approved Mircera (methoxy polyethylene glycol-epoetin β) for the treatment of anemia associated with chronic kidney disease (CKD) in pediatric patients on hemodialysis.

The drug is specifically indicated for patients aged 5 to 17 years who are converting from another erythropoiesis stimulating agent (ESA) after their hemoglobin level was stabilized with an ESA (epoetin α/β or darbepoetin α).

In this patient population, Mircera should be administered intravenously once every 4 weeks based on total weekly epoetin α or darbepoetin α dose at the time of conversion.

Mircera was approved following an open-label, multicenter trial of 64 pediatric patients aged 5 to 17 years with CKD who were on hemodialysis and had stable hemoglobin levels while previously receiving another ESA.

Each patient was treated with Mircera intravenously once every 4 weeks for a total of 20 weeks.

Safety and efficacy data for the new approval were obtained from both the above trial and other trials of Mircera in adult patients with CKD.

—Christina Vogt

Reference:

FDA approves Mircera for anemia associated with chronic kidney disease in pediatric patients on dialysis [press release]. US Food and Drug Administration. June 7, 2018. https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm610210.htm?utm_campaign=Oncology 6%2F7%2F18&utm_medium=email&utm_source=Eloqua&elqTrackId=cec3e3208e9b4c35ba3c9744cf320c6c&elq=915bad9ff9634a32b227ca945b1fd6ff&elqaid=3829&elqat=1&elq Accessed on June 7, 2018.