Despite FDA approval, antianemia drug might still be mothballed

November 16, 2007

Roche obtains FDA approval for Mircera for dialysis patients, but a patent dispute with Amgen could tie up its marketing in the United States.

Roche has won approval for its antianemia drug Mircera (methoxy polyethylene glycol-epoetin beta) for chronic renal failure patients. But the approval is viewed as a Pyrrhic victory of sorts, since Amgen, maker of the erythropoiesis-stimulating agents Aranesp and Epogen, has successfully claimed that Roche's product infringes on its patent. Roche plans to appeal the patent infringement decision. If the appeal fails, analysts believe patients will have to wait till 2013 before Mircera is marketed in this country.

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