FDA Approves ENBREL to Treat Psoriasis; New Convenient Treatment Provides Rapid and Significant Relief of Symptoms
THOUSAND OAKS, Calif. & COLLEGEVILLE, Pa., Apr 30, 2004 -- Amgen Inc. (Nasdaq:AMGN) and Wyeth Pharmaceuticals, a
division of Wyeth (NYSE:WYE), today announced that ENBREL(R)
(etanercept) has been approved by the U.S. Food and Drug
Administration (FDA) 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. The psoriasis
indication marks the fifth disease for which ENBREL has received an
FDA approval in just over five years.
Psoriasis is a chronic immune disorder in which certain immune
cells become overactive and release proteins called cytokines. Tumor
necrosis factor (TNF) is one of those cytokines that helps regulate
the body's immune response to infection and inflammation. In patients
with psoriasis, TNF causes inflammation, which can lead to the
formation of painful, often disfiguring psoriasis plaques. As an
anti-TNF therapy, ENBREL binds to the over-produced TNF and renders it
biologically inactive, which can result in a significant reduction in
"Both physicians and patients have expressed a desire for new
options to treat psoriasis. ENBREL rapidly cleared psoriasis in many
patients and was generally well-tolerated in two large clinical
trials," said Laura Hamill, vice president and general manager of
Amgen's Inflammation Business Unit. "This approval in psoriasis,
coupled with our previous indication in psoriatic arthritis,
reinforces our commitment to dermatology and our core aspiration of
providing treatments that can dramatically improve people's lives."
The approval was based on data from two Phase 3 studies totaling
more than 1,200 adults with plaque psoriasis who were treated with
ENBREL for up to 12 months. ENBREL was approved with a step-down
dosing regimen of 50 mg administered twice-weekly for three months,
followed by a maintenance dose of 50 mg weekly thereafter. ENBREL
demonstrated rapid and significant clearing in many patients at this
recommended dosing regimen. Patients who are treated with ENBREL
require no routine laboratory monitoring specific to ENBREL therapy
other than standard medical oversight.
"Dermatologists are already familiar with ENBREL because it is the
only approved treatment for psoriatic arthritis. The product is now
poised to emerge as a real-world treatment option for psoriasis that
can help satisfy the needs of community dermatologists and their
patients," explained Gary L. Stiles, M.D., executive vice president
and chief medical officer of Wyeth Pharmaceuticals. "Dermatologists
have prescribed ENBREL because of its extensive clinical experience
and its established safety profile -- ENBREL has 12 years of
collective clinical experience in a variety of indications and has
been used in more than 234,000 patients worldwide across indications."
"My psoriasis was devastating -- I suffered with the disease for
many years. I was in so much pain that I stopped being physically
active and gained over 100 pounds," said ENBREL patient, Matt J. "Some
of the traditional treatments I'd tried in the past were time
consuming, inconvenient and almost worse than the disease itself.
Taking ENBREL has been very easy and my skin has cleared and has
stayed clear. As a result, I'm not worried about the pain that I once
felt from my psoriasis and I'm more outgoing and physically active."
In a Phase 3 study, nearly half (46 percent) of patients receiving
50 mg twice-weekly of ENBREL achieved the primary endpoint of a 75
percent or greater improvement in the Psoriasis Area Severity Index
(also known as PASI 75) at three months. These patients were "stepped
down" to half the dose and then continued treatment for an additional
three months. At six months, the percentage of patients achieving a
PASI 75 response was maintained following dose reduction.
"Psoriasis can be a chronic, disabling disease requiring
continuous treatment. ENBREL was shown to provide rapid and
significant relief of psoriasis in many patients," said Alice
Gottlieb, M.D., Ph.D., director of the Clinical Research Center at the
University of Medicine and Dentistry of the New Jersey-Robert Wood
Johnson Medical School. "Additionally, in one clinical trial, patients
who stopped treatment did so without experiencing disease flare or
rebound. The trial also demonstrated, that upon retreatment with
ENBREL the overall response rates were similar to those seen after
ENBREL was generally well-tolerated in both Phase 3 studies.
Adverse events were similar to those reported in previous clinical
trials in other indications. The most common adverse events in the
ENBREL group when compared to placebo were injection site reactions.
An estimated 4.5 million people in the United States suffer from
psoriasis and 1.5 million have moderate to severe plaque psoriasis.
The disease is characterized by chronic inflammation of the skin. This
inflammation helps drive the formation of red, itchy skin plaques that
are often painful and disfiguring. Tumor necrosis factor (TNF) is
found at increased levels in psoriatic plaques and plays a critical
role in their formation and continued existence.
ENBREL is the only fully human TNF receptor approved to reduce
signs and symptoms, improve physical function, and inhibit the
progression of structural damage in patients with moderately to
severely active rheumatoid arthritis (RA), and to reduce the signs and
symptoms and inhibit the progression of structural damage of active
arthritis in patients with psoriatic arthritis. ENBREL is the only
biologic therapy approved for first-line treatment of RA patients, and
can be used alone or in combination with methotrexate. It is approved
to reduce the signs and symptoms of moderately to severely active
polyarticular-course juvenile rheumatoid arthritis (JRA) in patients
who have had an inadequate response to one or more disease-modifying
antirheumatic drugs (DMARDs). It is also the first biologic approved
to treat the signs and symptoms in patients with active ankylosing
spondylitis (AS). 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.
ENBREL has been used by more than 234,000 patients worldwide
ENBREL acts by binding TNF, one of the dominant inflammatory
cytokines or regulatory proteins that play an important role in both
normal immune function and the cascade of reactions that causes the
inflammatory process of RA, JRA, psoriasis, psoriatic arthritis and
AS. The binding of ENBREL to TNF renders the bound TNF biologically
inactive, resulting in significant reduction in inflammatory activity.
Since the product was first introduced, the following have been
reported in patients using ENBREL:
- Serious Infections
- Many occurred in people prone to infection, such as those
with advanced or poorly controlled diabetes
- Some serious infections were fatal
- Rare cases of tuberculosis
- What to do/Not to do
- Do not start ENBREL if you have an infection or are
allergic to ENBREL or its components.
- Tell your doctor if you are prone to infection.
- Stop ENBREL if a serious infection occurs.
- Contact your doctor if you have questions about ENBREL or
develop an infection.
- Tell your doctor if you have ever been treated for heart
- Serious nervous system disorders such as multiple sclerosis,
seizures, or inflammation of the nerves of the eyes
- Tell your doctor if you have ever had any of these
disorders or if you develop them after starting ENBREL.
- Rare reports of serious blood disorders (some fatal)
- Contact your doctor immediately if you develop symptoms
such as persistent fever, bruising, bleeding, or paleness.
- In medical studies of all TNF-inhibitors, a higher rate of
lymphoma (a type of cancer) was seen compared to the general
population, however, the risk of lymphoma may be up to several
fold higher in RA and psoriasis patients. The role of
TNF-inhibitors in the development of lymphoma is unknown.
- The incidence of other cancers has not increased with extended
exposure to ENBREL and is similar to the expected rate.
- ENBREL can also cause injection site reactions.
- In a medical study of patients with JRA, infections,
headaches, 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 rarely,
including serious infections (2 percent) and
depression/personality disorder (1 percent).
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. Additional information about ENBREL, including
full Prescribing Information, can be found on the Web site sponsored
by the companies at www.enbrel.com or by calling toll free 888-4ENBREL
Amgen is a global biotechnology company that discovers, develops,
manufactures and markets important human therapeutics based on
advances in cellular and molecular biology.
Wyeth Pharmaceuticals, a division of Wyeth, has leading products
in the areas of women's health care, cardiovascular disease, central
nervous system, inflammation, hemophilia, oncology and vaccines. 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,
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Andrea Rothschild, 805-447-4587 (media)
Cary Rosansky, 805-447-1060 (investors)
Jenifer Antonacci, 484-865-5220 (media)
Justin Victoria, 973-660-5340 (investors)