Amgen and Wyeth Statement on FDA Announcement About Tumor Necrosis Factor (TNF) Blockers

AmgenAmgen (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.

Most Popular Now

In wine, there's health: Low levels of alcohol goo…

While a couple of glasses of wine can help clear the mind after a busy day, new research shows that it may actually help clean the mind as well. The new study, which appe...

Sanofi to acquire Ablynx for €3.9 Billion

Sanofi and Ablynx, a biopharmaceutical company engaged in the discovery and development of Nanobodies®, entered into a definitive agreement under which Sanofi will offer ...

Repurposed drug found to be effective against Zika…

In both cell cultures and mouse models, a drug used to treat Hepatitis C effectively protected and rescued neural cells infected by the Zika virus - and blocked transmiss...

Interim publications of randomized trials make new…

Early results from randomized trials are sometimes published before the trial is completed. The results of such interim publications may generate a great deal of interest...

Drug trial protocol redactions by industry sponsor…

New research published by the Journal of the Royal Society of Medicine exposes the extent of redactions in protocols for industry-sponsored randomised drug trials. Trial ...

Advanced Accelerator Applications receives FDA ap…

Novartis AG (NYSE: NVS) announced that Advanced Accelerator Applications, a subsidiary of Novartis Groupe S.A., has received US Food and Drug Administration (FDA) approva...

Blood vessel-on-a-chips show anti-cancer drug effe…

Researchers at the Institute of Industrial Science (IIS), the University of Tokyo, CNRS and INSERM, report a new organ-on-a-chip technology for the study of blood vessel ...

Guidelines extended to improve the use of feedback…

Researchers have recommended changes to international guidelines used in the development of clinical trials in an effort to gain information about the impact of the treat...

Brilinta significantly reduces CV events and coron…

AstraZeneca today announced results from a new sub-analysis of the Phase III PEGASUS-TIMI 54 trial, demonstrating a risk reduction of 19% in MACE (the composite of CV dea...

Roche reports good results in 2017

In 2017, Group sales rose 5% to CHF 53.3 billion. Core operating profit grew 3% and Core EPS increased 5%, reflecting the good underlying business performance. On an IFRS...

FDA approves new treatment for certain digestive t…

The U.S. Food and Drug Administration today approved Lutathera (lutetium Lu 177 dotatate) for the treatment of a type of cancer that affects the pancreas or gastrointesti...

How old antibiotic compounds could become tomorrow…

As the fight against drug-resistant infections continues, University of Leeds scientists are looking back at previously discarded chemical compounds, to see if any could ...

Pharmaceutical Companies

[ A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Z ]