EPOGEN and Aranesp are effective and safe medicines when administered according to the Food and Drug Administration (FDA) label. Amgen only promotes the use of EPOGEN and Aranesp consistent with the FDA label. Hemoglobin maintenance is difficult and physicians are not necessarily acting inappropriately when patients' hemoglobin levels temporarily exceed the FDA label target range. CMS reimbursement guidelines are consistent with the FDA labeling policy and allow doctors to provide patients with the best possible care. Changes to current guidelines should be approached judiciously and based on the rigorous review of data and patient care.
The company will also submit written testimony to the House Ways & Means Committee, which is scheduled to hold a hearing Wednesday, Dec. 6, on safety and quality for Medicare beneficiaries with End Stage Renal Disease. That testimony will be posted to the company's web site under this link upon submission to the committee.
About Amgen
Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.com.
Contact: Amgen David Polk, 805-447-4613 (media) Arvind Sood, 805-447-1060 (investors)
Source: Amgen