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Roche CERA submission

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Roche's long-acting anemia agent CERA has an estimated mid-February 2007 user fee date following the firm's recent submission of a BLA, announced April 20. The firm is seeking an indication for anemia associated with chronic kidney disease. Roche highlighted the continuous erythropoietin receptor activator as having a distinct molecular interaction from that of other erythropoietin agents. The BLA is supported by six Phase III trials of patients treated every four weeks. Roche is continuing to point to CERA's dosing advantages. The firm also plans to submit a chemotherapy-induced anemia BLA in 2009 (1Pharmaceutical Approvals Monthly February 2006, p. 15)...

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