Amgen and Wyeth Pharmaceuticals, a division of Wyeth, issued a statement in response to the Food and Drug Administration (FDA) early communication regarding an ongoing safety review of Tumour Necrosis Factor (TNF) blockers (marketed as Remicade, Enbrel, Humira and Cimzia) and the possible association between the use of these medicines and the development of lymphoma and other cancers in children and young adults.
Amgen and Wyeth are committed to the safety of patients and have consistently updated the product labelling for Enbrel (etanercept) over the past decade. The companies maintain ongoing safety surveillance programs worldwide to analyze and evaluate safety reports, including reports of malignancies, from controlled and open-label clinical trials and patient registries, as well as reports received from healthcare professionals and patients. Amgen provided the FDA with information from both companies' adverse events databases and is continuing to work with the Agency to evaluate the overall risk benefit of Enbrel in paediatric patients.
The FDA has conducted an analysis of safety information provided by the manufacturers from all TNF blockers as well as that collected from its own adverse events reporting system (MedWatch). Based on it's preliminary review, the FDA has decided to conduct further analyses to evaluate the risks and benefits of TNF blockers in paediatric patients. The Early Communication mechanism has been used by the FDA on numerous occasions during the past year to inform the public about its ongoing safety reviews of drugs. The Agency's posting of this early communication means that FDA is considering the information but has not yet reached a conclusion.
Amgen and Wyeth support the ongoing FDA review of safety information for TNF blockers and remain committed to providing FDA with any additional information needed. According to the FDA early communication, "FDA has been aware of the possible association between the use of TNF blockers and the development of cancers. The prescribing information for all four TNF blockers warns about the possible risk of cancer." The FDA early communication also states, "At the current time, the FDA believes that the potential benefits of the use of TNF blockers outweigh the potential risks in certain children and young adults having one of the diseases for which the TNF blockers are approved to treat. Until the evaluation is completed, healthcare providers, parents, and caregivers should be aware of the possible risk of lymphoma and other cancers in children and young adults when deciding how to best treat these patients." Amgen and Wyeth agree, and as always, physicians and patients, or their caregivers, should carefully evaluate the benefits and risks of Enbrel before initiating therapy.
Enbrel was first approved for juvenile idiopathic arthritis (JIA), formerly called juvenile rheumatoid arthritis, in 1999, and this is the only approved use for Enbrel in the paediatric population. It is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients ages 2 and older. Serious infections, including tuberculosis (TB), have happened in patients taking Enbrel. Some of these serious infections have been fatal. Many serious infections occurred in people prone to infection. Serious infections have also occurred in patients with advanced or poorly controlled diabetes.
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.