Amgen Issues Statement on Prescribing Information Update for Erythropoiesis-Stimulating Agents (ESAs)

On April 9, 2009, Amgen updated the prescribing information for EPOGEN® (Epoetin alfa) and Aranesp® (darbepoetin alfa) to include a warning of the potential for antibody-mediated pure red cell aplasia (PRCA) when erythropoiesis-stimulating agents (ESAs) are administered to treat anemia associated with interferon alfa or pegylated interferon alfa and ribavirin therapy in patients with hepatitis C virus infection. ESAs are not approved by the U.S. Food and Drug Administration (FDA) for this use. This label update applies to all products in the ESA class of medicines.

PRCA is a known risk in treatment with ESAs in the approved indications and has been included as a warning in the prescribing information. PRCA is a rare to very rare adverse drug reaction in which patients who are treated with ESAs develop antibodies to the ESA. These antibodies inactivate ESAs and naturally produced erythropoietin. The resulting anemia does not respond to treatment with an ESA. Patients with antibody-mediated PRCA need to receive red blood cell transfusions on a regular basis typically over a number of months.

The WARNINGS sections of the ESA labels have been revised and now read:

Pure Red Cell Aplasia
Cases of pure red cell aplasia (PRCA) and of severe anemia, with or without other cytopenias, associated with neutralizing antibodies to erythropoietin have been reported in patients treated with EPOGEN/Aranesp/PROCRIT. This has been reported predominantly in patients receiving ESAs by subcutaneous administration. PRCA has also been reported in patients receiving ESAs while undergoing treatment for hepatitis C with interferon and ribavirin.

As part of its ongoing commitment to rapid and transparent communication regarding emerging safety issues, Amgen has worked with the FDA to monitor the issue and communicate the potential risk to physicians, which it will distribute through multiple channels. The company reaffirms that, when used according to the product labeling, ESAs remain safe and effective.

The updated labels are available on the product Web sites: www.epogen.com and www.aranesp.com.

Contact:

Amgen, Thousand Oaks
Emma Hurley, 805-447-7845 (media)
Arvind Sood, 805-447-1060 (investors)

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