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Statement Following CMS MEDCAC Meeting on ESAs in Chronic Kidney Disease

THOUSAND OAKS, Calif., (March 24, 2010) – Amgen Inc. today issued the following statement regarding the Centers for Medicare and Medicaid Services (CMS) Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) Meeting that reviewed the available evidence on the use of erythropoiesis-stimulating agents (ESAs) to manage anemia in patients with chronic kidney disease (CKD).

Amgen appreciates the importance of this evidence review by CMS as it has payment policies in place that guide the use of ESAs in CKD patients.

Amgen and many members of the nephrology community who participated in today’s meeting, including patients and healthcare providers, strongly believe the body of evidence supports a hemoglobin range of 10-12 g/dL as outlined in the current FDA approved labeling.

Amgen looks forward to working with CMS as they continue to review the evidence and evaluate any potential changes in payment policies for ESAs in CKD.

We expect that the discussions at the FDA drug advisory committee meeting later this year will provide important insights that will inform decisions about coverage and reimbursement policies for ESAs in patients with CKD.


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