Enbrel(R) (etanercept) Application for the Treatment of Pediatric Psoriasis to be Discussed at FDA Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) Meeting
ENBREL Reviewed As Potential New Treatment Option for Children and
Adolescents with Chronic Moderate to Severe Plaque Psoriasis Who Have
Tried Another Therapy
THOUSAND OAKS, Calif.--(BUSINESS WIRE)--June 18, 2008--Amgen
(NASDAQ:AMGN) announced that the supplemental Biologics License
Application (sBLA) for ENBREL for the treatment of pediatric patients
with chronic moderate to severe plaque psoriasis who have tried
another therapy will be discussed today at a meeting of the DODAC.
Moderate to severe plaque psoriasis is a serious, chronic inflammatory
disease that can have both physical and psychosocial impact. According
to a study published in the British Journal of Dermatology, chronic
psoriasis can have as much of an impact on a child's physical,
psychological and social functioning as other serious childhood
diseases such as asthma, epilepsy and diabetes.
"Despite the major impact of moderate to severe psoriasis on the
lives of children living with this condition, no topical or systemic
options are approved in the U.S. for chronic use in this indication,"
said Roger M. Perlmutter, M.D., Ph.D., executive vice president,
Research and Development, Amgen. "There is a clear unmet medical need
in this small, under-served population of children with chronic
moderate to severe plaque psoriasis."
In September 2007, Amgen submitted a sBLA to the U.S. Food and
Drug Administration (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.
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.
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 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
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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CONTACT: Amgen, Thousand Oaks
Sonia Fiorenza, office: 805-447-1604 (media)
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SOURCE: Amgen