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| Trade names | Mircera |
| AHFS/Drugs.com | Monograph |
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| Routes of administration | Intravenous,subcutaneous |
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Methoxy polyethylene glycol-epoetin beta, sold under the brand nameMircera, is a long-actingerythropoietin receptor activator (CERA) used for the treatment ofanaemia associated with chronic kidney disease.[3] It is the first approved, chemically modifiederythropoiesis-stimulating agent (ESA).[citation needed]
It is on theWorld Health Organization's List of Essential Medicines.[5] It was approved for medical use in the European Union,[4] Switzerland,[citation needed] and the United States in 2007.[3]
Methoxy polyethylene glycol-epoetin beta is made fromerythropoietin by chemically linking the N-terminal amino group or the ε-amino group of anylysine present in the protein with methoxy polyethylene glycol butanoic acid.[citation needed] The averagemolecular weight is approximately 60 kDa.[6] The drug stimulateserythropoiesis by interacting with the erythropoietin receptor on progenitor cells in thebone marrow.[6] It has a reduced receptor binding activity compared to other ESAs and but retains in vivo activity due to an extended serum half-life.[medical citation needed] It has anin vivo half-life of around 135 hours (5.6 days) as compared todarbepoetin alfa which has a half life of around 21 to 70 hours, the half life of which is three times that of the naturally occurring erthropoietin in the body.[medical citation needed]
AU.S. Federal Appeals Court ruled in September 2009, that Mircerainfringed a patent held byAmgen Inc. The court refused to lift aninjunction entered in the fall of 2008 which barred Roche from selling Mircera in the United States.[7] The injunction has since expired and Mircera has been available on the U.S. market since 2015.[8]
Mircera can reportedly replace traditionalerythropoietin drugs as ablood doping agent in endurance sports. The drug appears to fall under section S2 of the list of substances officially prohibited - in competition and out of competition - in France and by theWorld Anti-Doping Agency.[9]
In July 2008, Italian bicycle racerRiccardo Riccò was disqualified from theTour de France after reports that a urine sample tested positive for Mircera.[10][11] There had not previously been any public acknowledgment that a test for the new drug was being administered, or had even been developed yet. The Tour de France testing was done under the auspices of theFrench Cycling Federation and theFrench Anti-Doping Agency, not theUnion Cycliste Internationale.[12][13]
