Continuous erythropoitin receptor activator

Continuous erythropoietin receptor activator (CERA) is the generic term for drugs in a new class of third-generation erythropoiesis-stimulating agents (ESAs). In the media, these agents are commonly referred to as 'EPO', short for erythropoietin. CERAs have an extended half-life and a mechanism of action that promotes increased stimulation of erythropoietin receptors compared with other ESAs.

Under the trade name Mircera, Roche Pharmaceuticals received approval from the U.S. Food and Drug Administration (FDA) in January 2008 to market a continuous erythropoiesis receptor activator (methoxy polyethylene glycol-epoetin beta) for the treatment of anemia in patients with chronic kidney disease, including in those undergoing dialysis. (Patent disputes between Amgen, which owns several patents relating to recombinant EPO variants, and Roche are blocking distribution of Mircera in the U.S. This issue appears to have been resolved since Fresenius Medical dialysis clinics in the US are now administering this drug.) Methoxy polyethylene glycol-epoetin beta had been approved by the European Commission in August 2007, and was made available in Europe at the start of 2008.

In terms of its structure, Mircera is similar to the previous synthetic EPO drugs, except that it is connected to a chemical called polyethylene glycol (PEG), which makes it last longer in the body. According to Roche, the product has the longest half-life of all FDA-approved erythropoiesis-stimulating agents (ESAs): up to 6 times longer than darbepoetin alfa and up to 20 times longer than epoetin. CERAs thus promise both lower dosing—significant owing to the high inherent cost of manufacturing recombinant protein drugs—and less frequent injections for patients. ESAs are administered via subcutaneous injections, often in doctor's offices for patients who lack the skill or dexterity to inject themselves, so the once- or twice-monthly dosing regimen for CERAs promises fewer costly, inconvenient office visits for patients requiring constant hemoglobin level maintenance for chronic kidney disease.

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