As a result of an analysis of broadly communicated clinical trial safety data on ESAs, in June 2008 the European Medicines Agency (EMEA) announced their intention to update the product information for all erythropoiesis-stimulating agents (ESAs) in Europe. In July 2008, the EMEA requested that further clarity around the proposed label change was to be provided by Regulatory Agencies in each European Member State country through the publication of a Dear Healthcare Professional Communication (DHPC). In parallel, Amgen followed the necessary regulatory procedure to update the Aranesp product information, for which notification of its approval by the European Commission has now been received. For the treatment of symptomatic chemotherapy induced anaemia in cancer patients (CIA), the EMEA product information on ESAs was updated to advise that:

"… in some clinical situations blood transfusion should be the preferred treatment for the management of anaemia in patients with cancer. The decision to administer recombinant erythropoietins should be based on a benefit-risk assessment with the participation of the individual patient, which should take into account the specific clinical context. Factors that should be considered in this assessment should include the type of tumour and its stage, the degree of anaemia, life-expectancy, the environment in which the patient is being treated and patient preference."

Amgen believes that ESAs have a positive benefit risk profile when used according to label. Treatment decisions in the CIA setting should be individualized to a specific cancer patient’s circumstances, based on an informed discussion between healthcare professional and patient on the benefits and risks of ESAs and transfusions. Amgen continues to be constructively engaged with EMEA, FDA and other regulatory authorities globally regarding appropriate ESA label guidance for physicians.