Amgen and Wyeth Pharmaceuticals issued a statement in response to the Food and Drug Administration (FDA) Early Communication regarding an ongoing safety review of Tumor 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
THOUSAND OAKS, CA, USA & COLLEGEVILLE, PA, USA | Jun 04, 2008 | Amgen (NASDAQ: AMGN) and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), issued a statement in response to the Food and Drug Administration (FDA) Early Communication regarding an ongoing safety review of Tumor 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. These individuals were treated with TNF blockers for Juvenile Idiopathic Arthritis (JIA), Crohn’s disease or other diseases.
Amgen and Wyeth are committed to the safety of patients and have consistently updated the product labeling for Enbrel(R) (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 pediatric 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 pediatric 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.
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 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, there are nearly 300,000 children in America with some form of arthritis or rheumatic disease. 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 are impacted by the psychological and financial stress of chronic illness in a family member.
ABOUT ENBREL
ENBREL is a fully human soluble tumor necrosis factor (TNF) receptor. ENBREL was first approved in 1998 for moderate to severe rheumatoid arthritis and has more than 16 years of collective clinical experience.
ENBREL indications in the U.S.:
— ENBREL is indicated for reducing signs and symptoms, keeping joint damage from getting worse, and improving physical function in patients with moderate to severe rheumatoid arthritis. ENBREL can be taken with methotrexate or used alone.
— 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 is indicated for reducing signs and symptoms, keeping joint damage from getting worse, and improving physical function in patients with psoriatic arthritis. ENBREL can be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone.
— ENBREL is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.
— ENBREL is indicated for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Important Safety Information
What important safety information do I need to know about taking prescription ENBREL?
ENBREL is a type of protein called a tumor necrosis factor (TNF) blocker that blocks the action of a substance your body’s immune system makes called TNF. People with an immune disease, such as rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, or psoriasis, have too much TNF in their bodies. ENBREL can reduce the amount of active TNF in the body to normal levels, helping to treat your disease. But, in doing so, ENBREL can also lower the ability of your immune system to fight infections.
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. Do not start ENBREL if you have an infection or are allergic to ENBREL or its components. Once on ENBREL, if you get an infection or have any sign of an infection, including fever, cough, or flu-like symptoms, or have open sores, tell your doctor. Your doctor should test you for TB before starting ENBREL and should monitor you closely for signs and symptoms of TB.
Serious nervous system disorders, such as multiple sclerosis, seizures, or inflammation of the nerves of the eyes have been reported. There have been rare reports of serious blood disorders (some fatal).
In medical studies, more cases of lymphoma (a type of cancer) were seen in patients taking TNF blockers compared to similar patients who were not taking TNF blockers. The risk of lymphoma may be several-fold higher in people with rheumatoid arthritis and psoriasis; the role of TNF blockers in the development of malignancies is unknown.
Tell your doctor if you:
— Think you have, are being treated for, have signs of, or are prone to infection
— Have any open sores
— Have or have had TB or hepatitis B
— Have ever been treated for heart failure
— Have ever had or develop a serious nervous system disorder
— Develop symptoms such as persistent fever, bruising, bleeding, or paleness while taking ENBREL
Common side effects in adult clinical trials were injection site reaction, infection and headache.
In a medical study of patients with JIA, infection, headache, abdominal pain, vomiting, and nausea occurred more frequently than in adults. The kinds of infections reported were generally mild and similar to those usually seen in children. Other serious adverse reactions were reported, including serious infection and depression/personality disorder.
If you have any questions about this information, be sure to discuss them with your doctor. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please visit www.enbrel.com or call 1-888-4ENBREL to request additional information, including the full U.S. Prescribing Information.
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.
SOURCE: Amgen
Post Views: 115
Amgen and Wyeth Pharmaceuticals issued a statement in response to the Food and Drug Administration (FDA) Early Communication regarding an ongoing safety review of Tumor 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
THOUSAND OAKS, CA, USA & COLLEGEVILLE, PA, USA | Jun 04, 2008 | Amgen (NASDAQ: AMGN) and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), issued a statement in response to the Food and Drug Administration (FDA) Early Communication regarding an ongoing safety review of Tumor 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. These individuals were treated with TNF blockers for Juvenile Idiopathic Arthritis (JIA), Crohn’s disease or other diseases.
Amgen and Wyeth are committed to the safety of patients and have consistently updated the product labeling for Enbrel(R) (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 pediatric 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 pediatric 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.
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 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, there are nearly 300,000 children in America with some form of arthritis or rheumatic disease. 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 are impacted by the psychological and financial stress of chronic illness in a family member.
ABOUT ENBREL
ENBREL is a fully human soluble tumor necrosis factor (TNF) receptor. ENBREL was first approved in 1998 for moderate to severe rheumatoid arthritis and has more than 16 years of collective clinical experience.
ENBREL indications in the U.S.:
— ENBREL is indicated for reducing signs and symptoms, keeping joint damage from getting worse, and improving physical function in patients with moderate to severe rheumatoid arthritis. ENBREL can be taken with methotrexate or used alone.
— 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 is indicated for reducing signs and symptoms, keeping joint damage from getting worse, and improving physical function in patients with psoriatic arthritis. ENBREL can be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone.
— ENBREL is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.
— ENBREL is indicated for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Important Safety Information
What important safety information do I need to know about taking prescription ENBREL?
ENBREL is a type of protein called a tumor necrosis factor (TNF) blocker that blocks the action of a substance your body’s immune system makes called TNF. People with an immune disease, such as rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, or psoriasis, have too much TNF in their bodies. ENBREL can reduce the amount of active TNF in the body to normal levels, helping to treat your disease. But, in doing so, ENBREL can also lower the ability of your immune system to fight infections.
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. Do not start ENBREL if you have an infection or are allergic to ENBREL or its components. Once on ENBREL, if you get an infection or have any sign of an infection, including fever, cough, or flu-like symptoms, or have open sores, tell your doctor. Your doctor should test you for TB before starting ENBREL and should monitor you closely for signs and symptoms of TB.
Serious nervous system disorders, such as multiple sclerosis, seizures, or inflammation of the nerves of the eyes have been reported. There have been rare reports of serious blood disorders (some fatal).
In medical studies, more cases of lymphoma (a type of cancer) were seen in patients taking TNF blockers compared to similar patients who were not taking TNF blockers. The risk of lymphoma may be several-fold higher in people with rheumatoid arthritis and psoriasis; the role of TNF blockers in the development of malignancies is unknown.
Tell your doctor if you:
— Think you have, are being treated for, have signs of, or are prone to infection
— Have any open sores
— Have or have had TB or hepatitis B
— Have ever been treated for heart failure
— Have ever had or develop a serious nervous system disorder
— Develop symptoms such as persistent fever, bruising, bleeding, or paleness while taking ENBREL
Common side effects in adult clinical trials were injection site reaction, infection and headache.
In a medical study of patients with JIA, infection, headache, abdominal pain, vomiting, and nausea occurred more frequently than in adults. The kinds of infections reported were generally mild and similar to those usually seen in children. Other serious adverse reactions were reported, including serious infection and depression/personality disorder.
If you have any questions about this information, be sure to discuss them with your doctor. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please visit www.enbrel.com or call 1-888-4ENBREL to request additional information, including the full U.S. Prescribing Information.
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.
SOURCE: Amgen
Post Views: 115
