Amgen and Wyeth Statement on FDA Announcement About Tumor Necrosis Factor (TNF...( THOUSAND OAKS Calif. and ...),Health

THOUSAND OAKS, Calif. and COLLEGEVILLE, Pa., Aug. 4 /PRNewswire-FirstCall/ -- Amgen (Nasdaq: AMGN) and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), issued a statement in response to the Food and Drug Administration (FDA) announcement regarding the results of a safety review of Tumor Necrosis Factor (TNF) blockers [marketed as Remicade(R) (infliximab), Enbrel(R) (etanercept), Humira(R) (adalimumab), Cimzia(R) (certolizumab pegol) and Simponi(R) (golimumab)]. This safety review was the subject of an FDA Early Communication in June 2008 pertaining to cases of malignancy in pediatric patients exposed to a TNF blocker. As a result of this review, the FDA has required strengthened warnings about the occurrence of lymphoma and other cancers in children and young adults using these medicines.

AMGEN AND WYETH STATEMENT:

Amgen and Wyeth believe that ENBREL continues to offer a favorable benefit-risk relationship for patients with the diseases for which it is indicated to treat, including moderate to severe Juvenile Idiopathic Arthritis (JIA). JIA can be a serious and potentially debilitating condition. Amgen will work with the FDA to update the U.S. Prescribing Information, and Medication Guide for ENBREL as described in the FDA communication which can be read at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm175803.htm. In addition, Amgen and Wyeth will communicate the revised product labeling to both physicians and patients.

ENBREL was first approved for JIA in the U.S. in 19
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