FDA Approves ENBREL to Induce Major Clinical Response in Patients With Rheumatoid Arthritis; Additional Data Demonstrates Increased Levels of Sustained Disease Control
THOUSAND OAKS, Calif. & COLLEGEVILLE, Pa.--(BUSINESS WIRE)--Sept.
28, 2004--Enbrel(R) (etanercept) is the first and only biologic to
receive an indication by the U.S. Food and Drug Administration (FDA)
to induce a Major Clinical Response in patients with rheumatoid
arthritis (RA), Amgen Inc. (Nasdaq:AMGN) and Wyeth Pharmaceuticals, a
division of Wyeth (NYSE:WYE), announced today. In addition, the FDA
approved updated radiographic data in the ENBREL label, which
demonstrated that more than half of ENBREL patients observed in an
open-label long-term study experienced no progression of joint damage
for up to five years.
"Achieving a Major Clinical Response represents a significantly
high level of symptom control over a sustained period of time," said
Beth Seidenberg, M.D., chief medical officer and senior vice president
of global development, Amgen. "The impressive treatment response
observed with ENBREL should become a new benchmark for patients with
RA and their physicians in evaluating the success of therapy."
Major Clinical Response is defined as achieving an American
College of Rheumatology 70 response (ACR 70) for six consecutive
months. ACR response scores are categorized as ACR 20, ACR 50 and ACR
70 with ACR 70 being the highest level of sign and symptom control in
this evaluation system. ACR response scores measure improvement in RA
disease activity, including joint swelling and tenderness, pain, level
of disability and overall patient and physician assessment.
In addition to the Major Clinical Response indication, the ENBREL
label was updated to include data which showed that at five years,
patients with early, active RA continued to demonstrate inhibition of
joint damage and more than half (55 percent) had no progression of
"For patients with RA and their physicians, ENBREL can offer a
proven treatment that provides significant and sustained symptom
relief. Moreover, ENBREL has demonstrated the ability to halt the
progression of joint damage for up to five years for most patients,"
said Gary L. Stiles, M.D., executive vice president and chief medical
officer of Wyeth Pharmaceuticals. "Improving signs and symptoms and
halting the progression of joint damage can help a patient's ability
to perform activities of daily living."
More than two million Americans have RA, which is a chronic and
progressive disease that causes stiffness, swelling and limitation in
the motion and function of multiple joints. If RA is left untreated,
patients can become disabled from progressive joint damage caused by
the disease, limiting their ability to function.
ENBREL is the only fully human TNF receptor approved to reduce
signs and symptoms, induce Major Clinical Response, inhibit the
progression of structural damage, and improve the physical function in
patients with moderately to severely active RA. ENBREL is also
indicated 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 in the U.S.
for first-line treatment of RA patients, and can be used alone or in
combination with methotrexate.
ENBREL 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
DMARDs. It is also the only biologic approved in the U.S. 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 250,000 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 involved in 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-blockers, 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-blockers in the development of lymphoma is
-- The incidence of other cancers has not increased with 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,
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.
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Nurha Hindi, 805-447-6287 (media)
Laura Biswas, 805-447-1060 (investors)
Doug Petkus, 484-865-5140 (media)
Justin Victoria, 973-660-5340 (investors)