FDA Review May Prompt Panel to Propose Stricter Standards for Amgen’s Aranesp

FDA reviewers in a report released Thursday express doubt that Amgen’s Aranesp is a safe and effective treatment to raise hemoglobin levels in patients with anemia caused by chronic kidney disease. Members of the FDA’s Cardiovascular and Renal Drugs Advisory Committee will consider the agency’s comments at an Oct. 18 meeting to discuss the results of the TREAT (Trial to Reduce Cardiovascular Events with Aranesp Therapy) study of Aranesp (darbepoetin alfa) and three other large trials of epoetin alfa.
Drug Industry Daily