Abbott Laboratories Receives Positive Opinion for HUMIRA(R) Rheumatoid Arthritis Label Extension From European Medicines Evaluat
06 Mai 2004 - 1:00PM
PR Newswire (US)
Abbott Laboratories Receives Positive Opinion for HUMIRA(R)
Rheumatoid Arthritis Label Extension From European Medicines
Evaluation Agency - Extension to Incorporate Reduction in the Rate
of Joint Damage Progression and Improvement in Physical Function in
Adults With RA - ABBOTT PARK, Ill., May 6 /PRNewswire-FirstCall/ --
Abbott Laboratories today announced that the European Medicines
Evaluation Agency (EMEA) has granted a positive opinion for
HUMIRA(R) (adalimumab) label extension for reducing the rate of
progression of joint damage as measured by X-ray and improving
physical function in adults with rheumatoid arthritis (RA), when
given in combination with methotrexate. This positive opinion comes
seven months after European Commission approval to market HUMIRA
and provides new information for physicians and patients as they
consider options for treating RA. In the United States, HUMIRA was
approved Dec. 31, 2002, for both reducing signs and symptoms of RA
and inhibiting the progression of structural damage. In October
2003, Abbott submitted a supplemental Biologics Licensing
Application (sBLA) to the U.S. Food and Drug Administration (FDA)
seeking approval for the use of HUMIRA to improve physical function
in patients with moderately to severely active RA. The positive
opinion from EMEA is based on clinical data from one study with RA
patients with a mean disease duration of approximately 11 years
that showed a statistically significant difference for change in
modified total Sharp score, which assesses bone erosion and
joint-space narrowing by looking at patient X-rays. This score was
measured at six months, and was maintained at 12 months for
patients in the study treated with HUMIRA 40 mg every other week
and methotrexate. Improvements were maintained through two years of
HUMIRA treatment. Patients receiving HUMIRA and methotrexate
demonstrated less radiographic progression at one year than
patients receiving methotrexate alone. Improvements in physical
function and quality of life, as measured by a patient's ability to
perform normal daily activities, such as getting dressed, walking
and climbing stairs, were established and maintained with HUMIRA
through two years of HUMIRA treatment in this study. RA patients
who received HUMIRA and methotrexate saw less bone erosion and
joint-space narrowing at six and 12 months than patients taking
only methotrexate. Researchers assessed bone erosion and
joint-space narrowing using Sharp scores. "One important measure of
an RA treatment's success is its ability to slow the devastating
joint and bone damage that occurs in so many RA patients. This
destruction has a direct impact on long-term quality of life for
patients," said Ferdinand C. Breedveld, M.D., a professor of
rheumatology at Leiden University, Leiden, Netherlands, and
chairman of the department of medicine at the Leiden University
Medical Center. Abbott originally received a positive opinion from
the EMEA in May 2003 for the treatment of adult RA and was granted
European Union approval to market HUMIRA in September 2003. To
date, HUMIRA has been approved in 41 countries and launched in 26.
Clinical trials are also underway evaluating the potential of
HUMIRA in early RA, juvenile rheumatoid arthritis (JRA), psoriasis,
psoriatic arthritis, ankylosing spondylitis and Crohn's disease.
"The positive opinion provides further validation of HUMIRA's
ability to help physicians and RA patients battle this
debilitating, life-long disease," said Holger Liepmann, senior vice
president, international operations, Abbott Laboratories. "Strong
patient acceptance is making HUMIRA the most successful global
launch in Abbott's history," Liepmann said. Abbott expects
worldwide HUMIRA sales to reach more than $700 million in 2004 and
more than $1.2 billion in 2005. HUMIRA is the first fully human
monoclonal antibody available in Europe for RA, and the first tumor
necrosis factor alpha (TNF-alpha) antagonist approved in Europe
with an indication for use with methotrexate or as monotherapy.
HUMIRA resembles antibodies normally found in the body. It works by
blocking tumor necrosis factor alpha, a protein that plays a
central role in the inflammatory responses of autoimmune diseases
such as RA. In the European Union, HUMIRA is indicated for the
treatment of moderate to severe, active RA in adult patients when
the response to disease modifying anti-rheumatic drugs (DMARDs),
including methotrexate, has been inadequate. The EMEA's positive
opinion will be reviewed by the European Commission, which is
expected to approve the label extension for HUMIRA for use in the
treatment of adult RA patients for reducing the rate of progression
of joint damage and to improve physical function. Authorizations
generally occur approximately 90 days after the issuance of the
EMEA opinion. To ensure maximum efficacy, HUMIRA is given in
combination with methotrexate. In Europe, HUMIRA can be given as
monotherapy in case of intolerance to methotrexate or when
continued treatment with methotrexate is inappropriate. The
recommended dose of HUMIRA is 40 mg every other week by
subcutaneous injection (a shot beneath the skin). Abbott offers
HUMIRA in specially designed pre-filled syringes so patients do not
have to mix and measure the medicine or leave their homes for
treatment. The pre-filled syringe features handles and a plunger
head designed for use by patients whose hands have been affected by
their RA. About RA More than 5 million people worldwide suffer from
RA, a chronic autoimmune disease that causes pain, swelling and
stiffness in the joints of hands, feet and wrists and often leads
to the destruction of joints. Unlike osteoarthritis, the most
common form of arthritis, RA is an autoimmune disease where joints
are inflamed, resulting in eventual destruction of the joint's
interior and surrounding bone. The long-term prognosis for patients
with RA can be poor, and as a result, many patients face increased
disability and premature death. Important Safety Information Common
adverse events (>1/100 and less than or equal to 1/10) at least
possibly causally related to HUMIRA include headache, dizziness,
respiratory tract and urinary tract infection, nausea, diarrhea,
sore throat, herpes simplex, abdominal pain, rash, pruritis and
anemia. Injection site pain was reported by >1/10 of patients.
Patients must be monitored closely for infections, including
tuberculosis (TB), before, during and after treatment with HUMIRA.
Treatment should not be initiated in patients with active
infections until infections are controlled. Patients who develop
new infections while using HUMIRA should be monitored closely.
HUMIRA should not be used by patients with active TB or other
severe infections such as sepsis and opportunistic infections.
HUMIRA should be discontinued if a patient develops a new serious
infection until infections are controlled. Physicians should
exercise caution when considering use of HUMIRA in patients with a
history of recurring infection or with underlying conditions that
may predispose patients to infections. TNF-antagonists, including
HUMIRA, have been associated in rare cases with exacerbation of
clinical symptoms and/or radiographic evidence of demyelinating
disease. Prescribers should exercise caution in considering the use
of HUMIRA in patients with pre-existing or recent-onset central
nervous system demyelinating disorders. HUMIRA should be used with
caution in patients with mild heart failure, and is contraindicated
in patients with moderate or severe heart failure. HUMIRA must be
discontinued in patients who develop new or worsening symptoms of
congestive heart failure. Abbott's Commitment to Immunology Abbott
is focused on the discovery and development of innovative
treatments for immunologic diseases. Founded in 1989, the Abbott
Bioresearch Center in Worcester, Mass., is a world-class discovery
and basic research facility committed to finding new treatments for
autoimmune diseases. Abbott Laboratories 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 55,000 people and markets its products in more
than 130 countries. Abbott's news releases and other information
are available on the company's Web sites at http://www.abbott.com/
or at http://www.abbottimmunology.com/ . DATASOURCE: Abbott
Laboratories CONTACT: International Media, Brian Kyhos,
+1-847-936-7988, U.S. Media, Kelly Morrison, +1-847-937-3802, or
Financial Community, John Thomas, +1-847-938-2655, all of Abbott
Laboratories Web site: http://www.abbott.com/
http://www.abbottimmunology.com/ Company News On-Call:
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