Abbott Announces U.S. and E.U. Regulatory Submissions Seeking Approval of HUMIRA(R) (Adalimumab) in Ankylosing Spondylitis (AS)

Abbott (NYSE: ABT)
announced it has simultaneously submitted a supplemental Biologics License
Application (sBLA) with the U.S. Food and Drug Administration (FDA) and a Type
II Variation to the European Medicines Agency (EMEA) seeking approval to
market HUMIRA(R) (adalimumab) as a treatment for ankylosing spondylitis (AS),
an inflammatory disease of the spine and spinal joints. Additionally, Abbott
announced today that the FDA approved HUMIRA for reducing the signs and
symptoms of active arthritis in patients with psoriatic arthritis and as a
first-line treatment for patients with moderate to severe rheumatoid arthritis
(RA). The EMEA granted similar approvals in August 2005.
AS is categorized as spondyloarthritis, the term for a group of closely
linked rheumatic diseases that can affect the spine and joints, which can also
cause inflammation of the eye, intestine, and skin. In its severe form, AS
can lead to fusion of the spine, causing extreme physical limitation.
"AS strikes young, mostly male patients in the prime of their lives,
limiting their ability to work or engage in everyday activities. The HUMIRA
filing is encouraging news for AS patients suffering from this potentially
devastating disease," said John Davis, M.D., M.P.H., associate professor of
medicine, director of Division of Rheumatology Clinical Research Center,
University of California, San Francisco.
Results from the ATLAS study (Adalimumab Trial Evaluating Long-Term
Efficacy and Safety in AS), a randomized, double-blind, placebo-controlled,
Phase III study conducted in the United States and Europe, were submitted as
part of the regulatory applications. The applications included six-month
results from ATLAS showing a significant reduction in signs and symptoms
(including back pain and inflammation), partial remission, and improvement of
health-related quality of life in patients with AS. The ATLAS findings will
be reported at the American College of Rheumatology congress in San Diego,
Calif., this November.

About Ankylosing Spondylitis
Ankylosing spondylitis (AS), or arthritis of the spine, is thought to be
an autoimmune disorder in which a human protein, tumor necrosis factor-alpha,
has been suggested to play a role in the disease development. AS is a form of
arthritis known as spondyloarthritis, which is a group of closely linked
rheumatic diseases that can affect the spine and joints, ligaments and tendons
and can cause inflammation of the eye, intestine, and skin. AS is a chronic
disease that primarily affects the spine but can also affect other joints and
ligaments, resulting in severe joint and back stiffness and deformity over
time.
Unlike many other rheumatic conditions, AS affects young adults, mostly
men, and commonly begins before the age of 35. AS is difficult to diagnose in
its early stages and is the most overlooked cause of persistent back pain in
young adults.
"This filing reaffirms Abbott's commitment to the research and development
of treatments for patients suffering from a variety of autoimmune diseases,"
said Alejandro Aruffo, Ph.D., vice president, Global Pharmaceutical
Development and Abbott Bioresearch Center, Abbott. "AS marks the third
disease indication for HUMIRA to be submitted for regulatory approval in the
United States and Europe."

Important Safety Information
Cases of tuberculosis (TB) have been observed in patients receiving
HUMIRA. Serious infections and sepsis, including fatalities, have been
reported with the use of TNF-blocking agents, including HUMIRA. Many of these
infections occurred in patients also taking other immunosuppressive agents
that in addition to their underlying disease could predispose them to
infections. Treatment with HUMIRA should not be initiated in patients with
active infections. The combination of HUMIRA and anakinra is not recommended.
TNF-blocking agents, including HUMIRA, have been associated in rare cases
with demyelinating disease and severe allergic reactions. Infrequent reports
of serious blood disorders have been reported with TNF-blocking agents. More
cases of malignancies have been observed among patients receiving TNF
blockers, including HUMIRA, compared to control patients in clinical trials.
These malignancies, other than lymphoma and non-melanoma skin cancer, were
similar in type and number to what would be expected in the general
population. There was an approximately four fold higher rate of lymphoma in
combined controlled and uncontrolled open label portions of HUMIRA clinical
trials. The potential role of TNF-blocking therapy in the development of
malignancies is not known.
The most frequent adverse events seen in the placebo-controlled clinical
trials in rheumatoid arthritis (HUMIRA vs. placebo) were injection site
reactions (20 percent vs. 14 percent), upper respiratory infection (17 percent
vs. 13 percent), injection site pain (12 percent vs. 12 percent), headache (12
percent vs. 8 percent), rash (12 percent vs. 6 percent) and sinusitis (11
percent vs. 9 percent). Discontinuations due to adverse events were 7 percent
for HUMIRA and 4 percent for placebo. As with any treatment program, the
benefits and risks of HUMIRA should be carefully considered before initiating
therapy.
The safety profile for patients with psoriatic arthritis treated with
HUMIRA in the clinical trials has been similar to the safety profile seen in
patients with RA.

About HUMIRA
HUMIRA is the only fully human monoclonal antibody approved by the FDA for
reducing signs and symptoms, inducing major clinical response, inhibiting the
progression of structural damage and improving physical function in adult
patients with moderately to severely active rheumatoid arthritis. HUMIRA can
be used alone or in combination with methotrexate (MTX) or other DMARDS
(Disease-Modifying Anti-Rheumatic Drugs).
HUMIRA is indicated for reducing the signs and symptoms of active
arthritis in patients with psoriatic arthritis. HUMIRA can be used alone or
in combination with DMARDS.
In Europe, HUMIRA, in combination with MTX, is indicated for the treatment
of moderate to severe, active RA in adult patients when the response to DMARDS
including MTX has been inadequate. HUMIRA is also indicated for the treatment
of severe, active and progressive joint RA in adults not previously treated
with MTX.
HUMIRA is indicated for the treatment of active and progressive psoriatic
arthritis in adults when the response to previous DMARD-therapy has been
inadequate.
Clinical trials are currently underway evaluating the potential of HUMIRA
in other autoimmune diseases.

Abbott's Commitment to Immunology
Abbott is focused on the discovery and development of innovative
treatments for immunologic diseases. The Abbott Bioresearch Center, founded
in 1989 in Worcester, Mass., United States, is a world-class discovery and
basic research facility committed to finding new treatments for autoimmune
diseases. More information about Abbott Immunology and HUMIRA, including full
prescribing information, is available on the Web site http://www.rxabbott.com,
or in the United States by calling Abbott Medical Information at 1-800-633-
9110.

About Abbott
Abbott is a global, broad-based health care company devoted to the
discovery, development, manufacture and marketing of pharmaceuticals and
medical products, including nutritionals, devices and diagnostics. The
company employs more than 60,000 people and markets its products in more than
130 countries.
Abbott's news releases and other information are available on the
company's Web site at http://www.abbott.com.

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