Company Is in Discussions with FDA About Enbrel(R) (etanercept) in Pediatric Psoriasis
THOUSAND OAKS, Calif.--(BUSINESS WIRE)--May 1, 2008--Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has asked the Company to participate in a meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) on June 18, 2008. The DODAC will review data supporting the supplemental Biologic License Application (sBLA) submitted by Amgen for the 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.
"Plaque psoriasis is a chronic disease of the immune system that can impair many aspects of the daily lives of children and teens. If approved by the FDA, ENBREL would be the first biologic or systemic therapy indicated to treat this disease in pediatric patients," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development for Amgen. "We look forward to the opportunity to discuss the benefits and risks of ENBREL treatment for these patients, who have few approved options to help manage their disease."
Data from a Phase 3 study included in the sBLA, which was published in the January 17, 2008 issue of the New England Journal of Medicine, showed that children and adolescents with moderate to severe plaque psoriasis who received treatment with ENBREL experienced significant improvements in the signs and symptoms of their disease compared to placebo. This study also demonstrated that ENBREL was generally well tolerated over this 48 week study.
According to the National Institutes of Health, up to 7.5 million Americans have psoriasis, a non-contagious, chronic disease in which the immune system causes skin cells to grow at an accelerated rate. Approximately 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. Psoriasis appears most often between the ages of 15 and 35, though it can strike in infancy or old age. Information from the American Academy of Dermatology suggests that the earlier the psoriasis appears, the more likely it is to be widespread and recurrent.
ENBREL is a soluble form of a fully human tumor necrosis factor (TNF) receptor and has more than 15 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.
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.
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