Application for ENBREL Granted Priority Review by FDA as First Product
To Be Considered for Treatment of Psoriatic Arthritis
SAN FRANCISCO, Nov. 11 /PRNewswire/ -- Phase 3 results of ENBREL(R)
(etanercept) studied in patients with psoriatic arthritis will be presented
this week at the 65th Annual American College of Rheumatology National
Scientific Meeting in San Francisco.
"Psoriatic arthritis is a devastating disease for which there are
currently no approved treatments," says Philip Mease, MD, Seattle Rheumatology
Associates, Swedish Medical Center Division of Clinical Research and Clinical
Professor, University of Washington. "These data, currently under review by
the FDA, indicate that ENBREL can significantly improve the signs and symptoms
of psoriatic arthritis in many patients."
This 24-week, multicenter, randomized, double-blind, placebo-controlled
study assessed the efficacy and tolerability of ENBREL (25-mg twice-weekly
subcutaneous injections) or placebo in 205 patients with psoriatic arthritis.
The primary endpoint was measured by the proportion of patients who met the
American College of Rheumatology preliminary criteria for improvement (ACR20),
which includes duration of morning stiffness, tender and swollen joint counts
and a patient as well as a physician global assessment. In addition, two
other measurements were utilized to study aspects of both the joint and skin
manifestations of psoriatic arthritis: 1) The Psoriatic Arthritis Response
Criteria (PsARC) measures improvement in tender and swollen joint score, along
with a series of global assessments; and 2) a subset of clinical study
patients was measured by improvement in the psoriasis area and severity index
(PASI). PASI measures improvement in both the amount of psoriatic plaque
throughout the body, as well as the severity of the disease.
Results from the study include:
-- 59 percent of 101 patients receiving ENBREL(R) (etanercept) achieved
an ACR20 response compared to 15 percent of 104 patients receiving
placebo, after 12 weeks of treatment.
-- 72 percent of patients receiving ENBREL achieved a treatment response
compared to 31 percent of patients receiving placebo after 12 weeks of
treatment, using the PsARC measurement.
-- 54 percent of patients receiving ENBREL for 24 weeks were assessed as
having clear or almost clear skin manifestations, as measured by the
dermatologists' global assessment, compared to 23 percent of patients
receiving placebo. At baseline, 20 percent of patients in each group
were clear or almost clear of skin disease.
Also in this study, a subset (62 patients receiving ENBREL and 66 patients
receiving placebo who had greater than 3 percent of their body covered by
psoriatic plaque) were evaluated for psoriasis activity. Results showed that:
-- 23 percent of patients receiving ENBREL improved by 75 percent or
better compared to 3 percent of patients receiving placebo, as
measured by the psoriasis area and severity index (PASI) score.
Adverse events were similar to those reported in previous trials of ENBREL
in patients with rheumatoid arthritis. There was no increase in the number of
serious adverse events occurring in patients receiving ENBREL as compared with
those receiving placebo. Only the rate of injection site reactions (ISRs) in
patients receiving ENBREL was statistically different compared to placebo
(36 percent vs. 9 percent).
These data are currently being reviewed by the U.S. Food & Drug
Administration (FDA) for potential approval of ENBREL for the treatment of
psoriatic arthritis. In September, the FDA granted "priority review" status
requiring that the FDA act on the supplemental Biologics License Application
(sBLA) within six months of submission date. Immunex submitted its sBLA for
ENBREL on July 16, 2001. ENBREL is the first product to be reviewed by the
FDA for the treatment of psoriatic arthritis.
"We are working with the FDA on this priority review of the application
because we know the need for treatment is great," says Leslie Garrison, M.D.,
M.P.H, senior vice president of clinical research and development for Immunex
Corporation (Nasdaq: IMNX).
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(R) (etanercept) to treat
RA 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 the progression of structural damage in patients with moderately to
severely active RA. ENBREL is the only tumor necrosis factor (TNF) inhibitor
approved for use without methotrexate. 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 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(R) (etanercept) 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 treated with ENBREL 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%).
Immunex Corporation and Wyeth-Ayerst Laboratories, a division of American
Home Products Corporation (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.
Wyeth-Ayerst Laboratories, a division of AHP, is a major research-oriented
pharmaceutical company with leading products in the areas of women's health
care, cardiovascular therapies, central nervous system drugs,
anti-inflammatory agents, infectious disease, hemophilia, oncology, and
vaccines. AHP 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 is also a 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 of Immunex Corporation,
+1-206-390-0406, or Doug Petkus of Wyeth-Ayerst, +1-610-902-7336;
or investors, Mark Leahy of Immunex Corporation, +1-206-389-4363
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