Roche Delays CERA Oncology Filing Until 2009
This article was originally published in Pharmaceutical Approvals Monthly
Roche is pushing back the timeline for filing its anti-anemia agent CERA, its continuous erythropoietin receptor activator, for the treatment of chemotherapy-associated anemia until 2009, the firm said Feb. 1
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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)...
Roche is on-track to file a BLA for its CERA long-acting anti-anemia agent in 2006 after four Phase III trials met their primary endpoint of hemoglobin level maintenance, the firm said Dec. 16
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