Canada

 

Health Canada Approves ENBREL(R)etanercept) for the Treatment of
ModeratelyTo Severely Active Rheumatoid Arthritis

Canada's First Biologic Therapy for Rheumatoid Arthritis Provides New
Treatment Option for Patients

TORONTO, Dec. 8 /PRNewswire/ -- Health Canada has approved ENBREL(R)
(etanercept) for use in Canada.  As Canada's first biologic therapy for
rheumatoid arthritis, ENBREL is approved in adults for reduction in signs
and symptoms of moderately to severely active rheumatoid arthritis in patients
who have had an inadequate response to one or more disease-modifying
antirheumatic drugs (DMARDs).  In addition, ENBREL can be used in combination with
methotrexate in adult patients who do not respond adequately to methotrexate
alone.  ENBREL vials will be commercially available for use in Canada
beginning March 2001 through a patient registry program that is accessible through the
patient's rheumatologist.

"ENBREL is a breakthrough treatment for Canadians with rheumatoid
arthritis," said Aldo Baumgartner, President and Chief Executive Office of Wyeth-Ayerst
Canada, Inc.  "It brings the hope of effective treatment to many patients
for whom existing medications have failed."

In a Phase 3 trial of 234 rheumatoid arthritis patients, responses were
rapid, often appearing within one to two weeks after initiation of therapy, and
nearly always occurred within 3 months.  At three months, study results
demonstrated that 62 percent of the patients receiving a 25 mg dose of ENBREL reached the
primary endpoint of 20 percent improvement by ACR criteria -- a composite
score of select measurements of RA symptoms including joint pain, joint swelling,
and patient and physician global assessment -- compared to 23 percent of the
patients in the placebo group.  At 6 months, the secondary endpoints of this
study demonstrated a 69 percent median improvement in pain (vs. 2 percent
for placebo), a 71 percent median improvement in tender joint counts (vs. 6
percent for placebo), a 51 percent median improvement in swollen joint counts (vs. 2
percent for placebo), and an 88 percent median reduction in duration of
morning stiffness (vs. 4 percent for placebo).

"ENBREL has given me my life back," says Rebecca McDonald.  "Before ENBREL,
I could barely get out of bed, let alone climb a set of stairs.  Now, I'm able
to run up a set of stairs, am active again with my family, and plan to resume
my teaching career."  Individual responses to ENBREL may vary.  In medical
studies, ENBREL worked for about two out of three people who used it.

In the United States, ENBREL is currently approved as first-line treatment
for reducing signs and symptoms and delaying structural damage in patients with
moderately to severely active rheumatoid arthritis.  ENBREL is also approved
for the treatment 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 medicines. ENBREL is the only TNF
inhibitor that can be used with or without methotrexate.

In Canada, supplemental applications for polyarticular-course JRA and
first-line treatment of moderately to severely active rheumatoid arthritis
in adults will be filed soon with Health Canada.

"ENBREL works at the source of the inflammation, interrupting the disease
cycle and providing rapid and dramatic relief from the painful effects of
rheumatoid arthritis," said Dr. Ed Keystone, Director, Centre for Advanced Therapeutics
in Arthritis at Mount Sinai Hospital in Toronto, Canada, and a rheumatologist
who has been involved in studies of ENBREL.  "Treatment with ENBREL has provided
these people with new hope -- where there was little before -- to return to
a more active and productive lifestyle."

About Rheumatoid Arthritis

According to the Arthritis Society of Canada, nearly 300,000 Canadians have
rheumatoid arthritis -- the most disabling form of arthritis that causes
pain, swelling, and severe limitations of movement that can lead to disability.

Joint inflammation can destroy cartilage, tendons and ligaments, wear away
bone and subsequently cause joint deformity.  People with rheumatoid arthritis
live on average 10 years less than those who do not suffer from rheumatoid
arthritis.  Rheumatoid arthritis can affect people at any age, but most
commonly people ages 25 to 50.  Women are three times more likely than men
to develop the disease.

ABOUT ENBREL

ENBREL acts by binding tumor necrosis factor (TNF).  TNF is one of the
dominant cytokines or proteins that play an important role in normal immune function
and the cascade of reactions that cause the inflammatory process of RA.  ENBREL
competitively inhibits binding of TNF molecules to the TNF receptor (TNFR)
sites.  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, SERIOUS INFECTIONS, SOME INVOLVING
DEATH, HAVE BEEN REPORTED IN PATIENTS USING ENBREL.  MANY OF THESE EVENTS
OCCURRED IN PATIENTS WHO WERE PRONE TO INFECTIONS, SUCH AS THOSE WITH
ADVANCED OR POORLY CONTROLLED DIABETES.  ENBREL SHOULD BE DISCONTINUED IN PATIENTS
WITH SERIOUS INFECTIONS.  DO NOT START ENBREL IF YOU HAVE AN INFECTION OF ANY
TYPE OR IF YOU HAVE AN ALLERGY TO ENBREL OR ITS COMPONENTS.  ENBREL SHOULD BE
USED WITH CAUTION IN PATIENTS PRONE TO INFECTION.

There have been rare reports of serious nervous system disorders such as
multiple sclerosis and/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.  There have also been rare reports of serious blood
disorders, some involving death.  Contact your doctor immediately if you develop
symptoms such as persistent fever, bruising, bleeding or paleness.  It is unclear if
ENBREL has caused these nervous system or blood disorders.  If your doctor
confirms serious blood problems, you may need to stop using ENBREL.

The most frequent adverse events in placebo-controlled clinical trials
involving 349 adults were injection site reactions (ISR) (37%), infections
(35%), and headache (17%).  Only the rate of ISR was higher than that of
placebo.  The most frequent adverse events in a methotrexate-controlled
clinical trial of 415 adults with early-stage RA were infections (64%), ISR
(34%), and headache (24%).  Only the rate of ISR was higher than that of
methotrexate.  In all 1,197 RA patients studied, malignancies were rare
(1%).

In a study of 69 patients with JRA, infections (62%), headache (19%),
abdominal pain (19%), vomiting (13%), and nausea (9%) occurred more frequently than in
adults. The types of infections reported in JRA patients were generally mild
and consistent with those commonly seen in children. Serious adverse
reactions reported rarely were chicken pox (3%), gastroenteritis (3%),
depression/personality disorder (1%), skin ulcer (1%), inflammation in parts
of the upper digestive tract (1%), group A streptococcal septic shock (1%),
type I diabetes mellitus (1%), and soft tissue and post-operative wound infection
(1% each).

Immunex Corporation and Wyeth-Ayerst Laboratories, a division of American
Home Products Corporation, market ENBREL in North America.  Other AHP affiliates
will market ENBREL outside of North America.  Immunex manufactures and
records sales of ENBREL in the United States and Canada.  Additional information
about ENBREL, including the U.S. full prescribing information, can be found on the
company-sponsored website at (www.enbrel.com) or by calling toll-free
888-4ENBREL (888-436-2735).

Immunex Corporation is a leading biopharmaceutical company dedicated to
improving lives through immune system science innovations.

American Home Products Corporation's Wyeth Ayerst division is a major
research-oriented pharmaceutical company with leading products in the areas
of women's health care, cardiovascular disease therapies, central nervous
system drugs, anti-inflammatory agents, vaccines, oncology and hemophilia products
and generic pharmaceuticals.

American Home Products Corporation is one of the world's largest
research-based pharmaceutical and health care products companies. It is a leader in the
discovery, development, manufacturing, and marketing of prescription drugs
and over-the-counter medications.  It also is a global leader in vaccines,
biotechnology and animal health care.

NOTE:  This news release contains forward-looking statements that involve
risks and uncertainties, including risks associated with clinical development,
regulatory approvals, our reliance on third-party manufacturers, product
commercialization and other risks described from time to time in the SEC
reports filed by Immunex, including the most recently filed Form 10-Q.  An
electronic version of this news release -- as well as additional information
about Immunex of interest to investors, customers, future employees and
patients -- is available on the Immunex home page at www.immunex.com.

SOURCE  Immunex Corporation

CO:  Immunex Corporation; Health Canada

ST:  Washington, Ontario

IN:  MTC BIO

SU:

12/08/2000 08:00 EST http://www.prnewswire.com

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