Based on Need for Adequate Disease Treatment Expedited Review Is Requested
SEATTLE, July 16 /PRNewswire/ -- Immunex Corporation (Nasdaq: IMNX)
announced today the filing of a fourth supplemental biologics license
application (sBLA) with the U.S. Food and Drug Administration (FDA) for
ENBREL(R) (etanercept). The filing requests approval of ENBREL for reducing
signs and symptoms of psoriatic arthritis including use with or without
methotrexate. It will be the first product ever reviewed by the FDA to treat
this disease.
Because there are no approved therapies for psoriatic arthritis, Immunex
has requested "priority review" status from the FDA, which, if granted, would
require the FDA to act on the ENBREL sBLA within six months of filing.
"Psoriatic arthritis is a miserable disease because patients not only
suffer pain, stiffness and joint destruction similar to rheumatoid arthritis,
but also from scaly patches of dry skin that can spread all over the body.
This takes quite a toll on the patient both physically and mentally," said
Mark Lebwohl, M.D., professor and chairman of dermatology at Mount Sinai
Medical Center in New York City. "In my practice, one out of every
10 psoriasis patients I examine suffers from psoriatic arthritis. My hope is
that with this filing we are one step closer to treating a disease that has
not yet seen adequate treatment."
ENBREL is the first biologic response modifier to seek FDA approval for
reducing the signs and symptoms of psoriatic arthritis, either for use alone
or as combination therapy (i.e., with methotrexate). Immunex is also filing a
supplemental new drug submission (sNDS) in Canada simultaneously for this same
indication. Data submitted in the filings are from Phase 2 and 3 clinical
trials demonstrating that patients with psoriatic arthritis experienced
significantly greater improvement in signs and symptoms of both the joint and
skin manifestations of their disease after treatment with ENBREL compared to
patients treated with placebo. ENBREL was generally well tolerated in these
trials, with adverse events similar to those reported in earlier studies with
the product.
"Most people do not view psoriatic arthritis as a serious disease," said
Gail Zimmerman, president and chief executive officer, National Psoriasis
Foundation. "The reality is that it's a devastating disease that combines the
crippling effects of rheumatoid arthritis with the inflamed, irritated plaques
on the skin associated with psoriasis."
ABOUT PSORIATIC ARTHRITIS
Like rheumatoid arthritis (RA), psoriatic arthritis is a chronic
inflammatory disease of the joints and connective tissue. The disease causes
joint pain and swelling that can lead to crippling along with inflamed and
irritated scaly red patches of skin throughout the body. It is a progressive
and debilitating disease and because there are no treatments specifically
approved for psoriatic arthritis, doctors often use therapies approved for RA,
including nonsteroidal anti-inflammatory drugs (NSAIDs) and disease modifying
anti-rheumatic drugs (DMARDs). However, no DMARDs are currently approved for
use in psoriatic arthritis. There are approximately 300,000 patients with
psoriatic arthritis in the United States and the disease affects both men and
women most commonly between the ages 30 and 50. Psoriatic arthritis patients
are generally treated by rheumatologists and dermatologists.
ABOUT ENBREL
An application for marketing approval of ENBREL was fast-tracked by the
U.S. Food and Drug Administration in 1998. Six months after the application
was submitted, the FDA approved ENBREL for reducing the signs and symptoms of
moderately to severely active RA in patients who have had an inadequate
response to one or more DMARDs. The following year, the FDA approved ENBREL
for reducing signs and symptoms of moderately to severely active
polyarticular-course juvenile rheumatoid arthritis in patients who have had an
inadequate response to DMARDs. In June 2000, the FDA approved ENBREL for
reducing signs and symptoms and inhibiting structural damage in patients with
moderately to severely active RA. ENBREL is the only tumor necrosis factor
(TNF) inhibitor approved for use both with methotrexate or alone. It is also
the only TNF inhibitor approved for use as a first-line therapy for RA.
ENBREL acts by binding TNF, one of the dominant cytokines or regulatory
proteins that play an important role in both normal immune function and the
cascade of reactions that cause the inflammatory process of RA and psoriatic
arthritis. 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 infections
occurred in patients who were prone to infections, such as those with advanced
or poorly controlled diabetes. Rare cases of tuberculosis have also been
reported. 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. Contact your physician if you have any questions
about ENBREL or infections.
There have been rare reports of 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. 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 ENBREL-treated 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 (NYSE: AHP), market ENBREL in North America. Other AHP
affiliates market ENBREL outside of North America. Immunex manufactures
ENBREL. Additional information about ENBREL, including full prescribing
information, can be found on the company-sponsored Web site at
(http://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: Except for the historical information contained herein, this news
release contains forward-looking statements that involve substantial risks and
uncertainties. Among the factors that could cause actual results or timelines
to differ materially are risks associated with research and clinical
development, regulatory approvals, our supply capabilities and reliance on
third-party manufacturers, product commercialization, competition, litigation
and other risk factors listed from time to time in reports filed by Immunex
with the SEC, including but not limited to risks described under the caption
"Important Factors That May Affect Our Business, Our Results of Operations and
Our Stock Price" within our most recently filed Form 10-Q. The
forward-looking statements contained in this news release represent our
judgment as of the date of this release. Immunex undertakes no obligation to
publicly update any forward-looking statements.
SOURCE Immunex Corporation
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CONTACT:
media, Robin Shapiro, +1-206-389-4040, or
investors, Mark Leahy, +1-206-389-4363, both of Immunex
Corporation
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