FDA approves long-acting ESA for dialysis-related anemia in children, adolescents

 

The Food and Drug Administration has approved methoxy polyethylene glycol-epoetin beta (Mircera) for the treatment of dialysis-related anemia in pediatric patients aged 5-17 years with chronic kidney disease whose hemoglobin had been stabilized with an erythropoiesis-stimulating agent (ESA).

The approval for this long-acting ESA was based on an open-label dose-finding trial of 64 patients aged 5-17 years. All patients had chronic kidney disease and were on hemodialysis, and had been previously treated with another ESA and achieved stable hemoglobin levels. Patients received Mircera intravenously every 4 weeks based on the total weekly dose of the previously used ESA (either epoetin alfa/beta or darbepoetin alfa), with dosage adjustments after the first dose as needed to maintain target hemoglobin levels.

Efficacy was based partly on how well target hemoglobin levels were maintained in this trial, but also on extrapolation from results of trials in adults. The safety profile in these pediatric patients was consistent with those previously observed in adults. Mircera is manufactured by Vifor Pharma.

More information on the approval of Mircera in this population can be found in the FDA release. The prescribing information for Mircera, initially approved in 2007, has also been updated.

[email protected]

 

The Food and Drug Administration has approved methoxy polyethylene glycol-epoetin beta (Mircera) for the treatment of dialysis-related anemia in pediatric patients aged 5-17 years with chronic kidney disease whose hemoglobin had been stabilized with an erythropoiesis-stimulating agent (ESA).

The approval for this long-acting ESA was based on an open-label dose-finding trial of 64 patients aged 5-17 years. All patients had chronic kidney disease and were on hemodialysis, and had been previously treated with another ESA and achieved stable hemoglobin levels. Patients received Mircera intravenously every 4 weeks based on the total weekly dose of the previously used ESA (either epoetin alfa/beta or darbepoetin alfa), with dosage adjustments after the first dose as needed to maintain target hemoglobin levels.

Efficacy was based partly on how well target hemoglobin levels were maintained in this trial, but also on extrapolation from results of trials in adults. The safety profile in these pediatric patients was consistent with those previously observed in adults. Mircera is manufactured by Vifor Pharma.

More information on the approval of Mircera in this population can be found in the FDA release. The prescribing information for Mircera, initially approved in 2007, has also been updated.

[email protected]

 

The Food and Drug Administration has approved methoxy polyethylene glycol-epoetin beta (Mircera) for the treatment of dialysis-related anemia in pediatric patients aged 5-17 years with chronic kidney disease whose hemoglobin had been stabilized with an erythropoiesis-stimulating agent (ESA).

The approval for this long-acting ESA was based on an open-label dose-finding trial of 64 patients aged 5-17 years. All patients had chronic kidney disease and were on hemodialysis, and had been previously treated with another ESA and achieved stable hemoglobin levels. Patients received Mircera intravenously every 4 weeks based on the total weekly dose of the previously used ESA (either epoetin alfa/beta or darbepoetin alfa), with dosage adjustments after the first dose as needed to maintain target hemoglobin levels.

Efficacy was based partly on how well target hemoglobin levels were maintained in this trial, but also on extrapolation from results of trials in adults. The safety profile in these pediatric patients was consistent with those previously observed in adults. Mircera is manufactured by Vifor Pharma.

More information on the approval of Mircera in this population can be found in the FDA release. The prescribing information for Mircera, initially approved in 2007, has also been updated.

[email protected]