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 (infliximab), Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab pegol) and Simponi (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 1999. It is estimated through postmarketing data that approximately 13,847 pediatric patients have been treated with ENBREL globally through February 2009, accounting for approximately 44,600 patient-years of exposure. Postmarketing cases of malignancies have been reported in pediatric patients treated with ENBREL.
Amgen and Wyeth are committed to patient safety and support the continued evaluation of the potential risks and benefits of TNF blockers for patients who are prescribed these therapies. Both companies maintain ongoing safety surveillance programs worldwide to review all data sources available to them, and work with regulatory agencies to update the label as appropriate based on emerging information. As always, physicians and patients or their caregivers should carefully evaluate the benefits and risks of ENBREL.
About juvenile idiopathic arthritis
ENBREL was first approved for juvenile idiopathic arthritis (JIA), formerly called juvenile rheumatoid arthritis, in 1999, and this is the only FDA-approved use for ENBREL in the pediatric population. ENBREL is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients ages 2 and older. ENBREL has been studied in JIA for up to nine years in controlled and open-label portions of a clinical study.
JIA is a systemic inflammatory disease that strikes children before age 16 and can cause painful joint swelling, deformity and stunted growth. According to the Arthritis Foundation, JIA can impair a child's ability to take part in physical activities, make daily activities such as schoolwork more difficult, and affect a child's physical appearance. Parents and siblings may be impacted by the psychological and financial stress of chronic illness in a family member.
About Amgen and Wyeth
Amgen and Wyeth Pharmaceuticals, a division of Wyeth, market ENBREL in North America. Wyeth markets ENBREL outside of North America. Immunex Corporation, a wholly owned subsidiary of Amgen, manufactures ENBREL.
Amgen discovers, develops, manufactures 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 and 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.
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, infectious disease, gastrointestinal health, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products.
Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products and non-prescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health. To learn more, visit www.wyeth.com.