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Amgen to Review Results From TREAT and Propose Updates to ESA Labeling for Chronic Renal Failure Patients at an FDA Advisory Committee Meeting Today
Date:10/18/2010

warnings to incorporate the specific stroke risk found in TREAT.

Amgen is proposing changes to the ESA labels that would limit treatment to patients who are most likely to benefit, specifically those with significant anemia (<10 g/dL), and who are at high risk for transfusion and for whom transfusion avoidance is considered clinically important, including those in whom it is important to preserve kidney transplant eligibility.  In addition to narrowing the patient population, Amgen is proposing a more conservative dosing algorithm in these patients. For CRF patients receiving dialysis – a population not studied in TREAT – the benefits demonstrated in registration clinical trials and supported by years of clinical practice experience are clear and remain unchanged.

"The nephrology community has, and will continue to gain, significant understanding about the treatment of anemia in patients with chronic kidney disease not on dialysis from this large and rigorously designed and conducted clinical trial," stated Robert Toto, M.D., University of Texas Southwestern Medical Center.  "First and foremost, TREAT has informed us that the risks of treatment may outweigh the benefits for some patients with chronic kidney disease and anemia who are not on dialysis. However, ESAs remain an important therapeutic option for patients on dialysis, where the benefits are clear, and for certain patients not on dialysis; specifically those with significant anemia in whom blood transfusion avoidance is important, especially to preserve eligibility for kidney transplantation, the preferred treatment option for patients with failing kidneys."

TREAT Study Design and Key FindingsTREAT enrolled 4,038 patients not on dialysis with type-2 diabetes and moderate anemia. Designed as a superiority study to demonstrate improved cardiovascular outcomes, patients enrolled in the study were randomized in a one-to-one ratio to receive either treatment with
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