Mircera Gets FDA Nod For CKD-Related Drug

June 13, 2018  Source: MedPage Today 265

Last week Thursday Mircera (methoxy polyethylene glycol-epoetin beta) an erythropoietin Stimulating Agent - the main drugs for leveling Amenia in patients (ESA) received approval from the FDA to treat children and teens on kidney dialysis, and who are converting from another ESA  as a result of hemoglobin stabilization.

The recent research that achieved the FDA approval for Mircera, had 64 patients, aged between 5 to 17 years old who suffered from chronic kidney disease (CKD) and were on kidney dialysis at the beginning of the study.  As a result of earlier ESA treatment with epoetin alfa/beta or darbepoetin, alfa patients had stable hemoglobin (HB) and used intravenous methoxy polyethylene glycol-epoetin beta every 4 to  20 weeks.

Out of the 64 patients, 48 patients had the drug with the suggested dosage, and at the end, 36 patients were evaluated. The final result indicated a significant change in hemoglobin concentration from baseline -0.15 g/dL (95% CI -0.49 to 0.2).  AS for the remaining 12 patients, one patient passed away, nine patients withdrew from the study due to receiving kidney transplants, one patient refused treatment, and two withdrew for administrative reasons.

Mircera is not recommended or indicated for the treating of cancer patients with chemotherapy-related anemia.

By Ddu