Amgen's Statement Following FDA CRDAC Meeting

On October 18, 2010 the U.S. Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) discussed the results from TREAT (the Trial to Reduce Cardiovascular Events with Aranesp® Therapy), conducted in patients not on dialysis, and how those results inform the appropriate use of erythropoiesis-stimulating agents (ESAs) in patients with chronic renal failure (CRF).

Amgen appreciates the deliberations of the Committee in discussing the benefits and risks of ESAs in the context of TREAT, which provided new information that should be considered in treating patients not on dialysis with CRF.

We look forward to continued discussions with the FDA regarding the Committee’s recommendations for clarifying the use of ESAs in patients with CRF not on dialysis and potential studies to further inform optimal use of ESAs in this area.