Priority Review is Granted Based on Need for Disease Treatment
SEATTLE, Sept. 17 /PRNewswire/ -- Immunex Corporation (Nasdaq: IMNX) and
Wyeth-Ayerst Laboratories, a division of American Home Products (NYSE: AHP),
announced today that the U.S. Food and Drug Administration (FDA) granted
"priority review" status for Immunex's supplemental Biologics License
Application (sBLA) to use ENBREL(R) (etanercept) in the treatment of psoriatic
arthritis. ENBREL is the first product ever reviewed by the FDA to treat the
signs and symptoms of psoriatic arthritis.
The FDA notified Immunex in writing today that the sBLA for ENBREL was
accepted for filing. Separate from the letter of notification, the FDA has
confirmed that the agency has assigned the ENBREL sBLA a "priority review"
status. Priority review status indicates that the FDA is to act on the ENBREL
sBLA within six months of submission date. Immunex submitted its sBLA for
ENBREL on July 16, 2001.
"We look forward to working with the FDA to expeditiously complete the
review process for ENBREL in the treatment of psoriatic arthritis," said
Leslie Garrison, senior vice president of clinical research and development at
Immunex. "Because this patient population of 300,000 people has yet to see an
FDA-approved treatment for psoriatic arthritis, we are pleased to be moving
forward with the review process under 'priority review' status."
Acceptance of the sBLA filing does not indicate that a license has been or
will be issued nor does it represent any evaluation of the adequacy of the
data submitted.
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 and, unlike RA, also causes
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 non-steroidal anti-inflammatory drugs (NSAIDs) and
disease modifying anti-rheumatic drugs (DMARDs). There are approximately
300,000 patients with psoriatic arthritis in the United States, and the
disease affects both men and women usually 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 one or more DMARDs. In June 2000, the FDA approved
ENBREL for reducing signs and symptoms and inhibiting the progression of
structural damage in patients with moderately to severely active RA. ENBREL is
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 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 juvenile RA (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%), serious infection (2%), depression/personality disorder
(1%), skin ulcer (1%), inflammation in parts of the upper digestive tract
(1%), and diabetes (1%).
Immunex Corporation and Wyeth-Ayerst Laboratories, a division of American
Home Products, 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, musculoskeletal therapies, infectious disease, hemophilia, oncology,
vaccines 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:
investors, Mark Leahy, +1-206-389-4363; or
media, Robin Shapiro, +1-206-389-4142, both of Immunex
Corporation; or media, Doug Petkus of Wyeth-Ayerst,
+1-610-902-7336
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