FDA Advisory Committee Recommends Enbrel(R) (etanercept) for the Treatment of Children and Adolescents with Chronic Moderate to Severe Plaque Psoriasis
THOUSAND OAKS, CA & COLLEGEVILLE, PA, USA | June 18, 2008 | Amgen (NASDAQ: AMGN) and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), today issued the following statement on the outcome of today’s meeting of the U.S. Food and Drug Administration’s (FDA) Dermatologic and Ophthalmologic Drug Advisory Committee (DODAC) regarding the expanded use of ENBREL in treating pediatric patients with chronic moderate to severe plaque psoriasis.
AMGEN AND WYETH STATEMENT:
The Committee recommended, with an 8-5 vote, to approve ENBREL for the treatment of moderate to severe plaque psoriasis in children. The DODAC panel also provided input to the FDA regarding use in patients with more severe plaque psoriasis.
Amgen and Wyeth are pleased the Committee adopted a position that is consistent with both companies’ perspective that the benefits outweigh the risks in the population studied and that use should be reserved for appropriate patients.
Amgen and Wyeth are hopeful that today represents an important step forward in working with the FDA to provide new treatment options for children living with moderate to severe plaque psoriasis. Despite the major impact this disease has on the lives of children and adolescents, there are currently no topical or systemic options approved in the U.S. for chronic use in this population. An expanded indication for ENBREL would address the unmet medical need for an approved and well-studied therapy in this small, under-served pediatric psoriasis patient population.
While the FDA often seeks the advice of an advisory committee, such as DODAC, when evaluating new drugs or expanded indications or new populations for already approved drugs, the FDA is not required to follow the Committee’s recommendation.
Amgen is committed to working with the FDA to provide patients, families and their physicians with another option to treat this disease. ENBREL is the only biologic or systemic therapy studied in a randomized, placebo-controlled, double-blind clinical trial of children and adolescents with moderate to severe plaque psoriasis that has been published in a peer-reviewed journal. This is the largest published study of any therapy in pediatric psoriasis patients.
Amgen is proposing a risk management program to foster appropriate use of ENBREL in this patient population. Education will be an important tool to help physicians, patients, and their guardians understand, and therefore mitigate, known and potential risks associated with the use of ENBREL.
In September 2007, Amgen submitted a supplemental biologics application (sBLA) to the FDA for the expanded use of ENBREL in treating pediatric patients with chronic moderate to severe plaque psoriasis who are inadequately controlled with topical therapy or who have received systemic therapy or phototherapy.
ABOUT PSORIASIS
According to the National Institutes of Health, up to 7.5 million Americans have psoriasis, a noncontagious, chronic disease in which the immune system causes skin cells to grow at an accelerated rate. Up to 80 percent of these patients have plaque psoriasis, which is characterized by painful and itchy, red, scaly patches. According to the National Psoriasis Foundation, about one-third of all psoriasis patients will develop the disease in childhood.
ABOUT ENBREL
ENBREL is a soluble form of a fully human tumor necrosis factor (TNF) receptor and has 16 years of collective clinical experience with an established safety profile. ENBREL was first approved in 1998 for moderate to severe rheumatoid arthritis and was later approved to treat children and adolescents with juvenile rheumatoid arthritis (now called juvenile idiopathic arthritis) in 1999. ENBREL was approved in 2004 to treat moderate to severe plaque psoriasis in adults.
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 and Wyeth Pharmaceuticals
Post Views: 100
FDA Advisory Committee Recommends Enbrel(R) (etanercept) for the Treatment of Children and Adolescents with Chronic Moderate to Severe Plaque Psoriasis
THOUSAND OAKS, CA & COLLEGEVILLE, PA, USA | June 18, 2008 | Amgen (NASDAQ: AMGN) and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), today issued the following statement on the outcome of today’s meeting of the U.S. Food and Drug Administration’s (FDA) Dermatologic and Ophthalmologic Drug Advisory Committee (DODAC) regarding the expanded use of ENBREL in treating pediatric patients with chronic moderate to severe plaque psoriasis.
AMGEN AND WYETH STATEMENT:
The Committee recommended, with an 8-5 vote, to approve ENBREL for the treatment of moderate to severe plaque psoriasis in children. The DODAC panel also provided input to the FDA regarding use in patients with more severe plaque psoriasis.
Amgen and Wyeth are pleased the Committee adopted a position that is consistent with both companies’ perspective that the benefits outweigh the risks in the population studied and that use should be reserved for appropriate patients.
Amgen and Wyeth are hopeful that today represents an important step forward in working with the FDA to provide new treatment options for children living with moderate to severe plaque psoriasis. Despite the major impact this disease has on the lives of children and adolescents, there are currently no topical or systemic options approved in the U.S. for chronic use in this population. An expanded indication for ENBREL would address the unmet medical need for an approved and well-studied therapy in this small, under-served pediatric psoriasis patient population.
While the FDA often seeks the advice of an advisory committee, such as DODAC, when evaluating new drugs or expanded indications or new populations for already approved drugs, the FDA is not required to follow the Committee’s recommendation.
Amgen is committed to working with the FDA to provide patients, families and their physicians with another option to treat this disease. ENBREL is the only biologic or systemic therapy studied in a randomized, placebo-controlled, double-blind clinical trial of children and adolescents with moderate to severe plaque psoriasis that has been published in a peer-reviewed journal. This is the largest published study of any therapy in pediatric psoriasis patients.
Amgen is proposing a risk management program to foster appropriate use of ENBREL in this patient population. Education will be an important tool to help physicians, patients, and their guardians understand, and therefore mitigate, known and potential risks associated with the use of ENBREL.
In September 2007, Amgen submitted a supplemental biologics application (sBLA) to the FDA for the expanded use of ENBREL in treating pediatric patients with chronic moderate to severe plaque psoriasis who are inadequately controlled with topical therapy or who have received systemic therapy or phototherapy.
ABOUT PSORIASIS
According to the National Institutes of Health, up to 7.5 million Americans have psoriasis, a noncontagious, chronic disease in which the immune system causes skin cells to grow at an accelerated rate. Up to 80 percent of these patients have plaque psoriasis, which is characterized by painful and itchy, red, scaly patches. According to the National Psoriasis Foundation, about one-third of all psoriasis patients will develop the disease in childhood.
ABOUT ENBREL
ENBREL is a soluble form of a fully human tumor necrosis factor (TNF) receptor and has 16 years of collective clinical experience with an established safety profile. ENBREL was first approved in 1998 for moderate to severe rheumatoid arthritis and was later approved to treat children and adolescents with juvenile rheumatoid arthritis (now called juvenile idiopathic arthritis) in 1999. ENBREL was approved in 2004 to treat moderate to severe plaque psoriasis in adults.
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 and Wyeth Pharmaceuticals
Post Views: 100
