announced that the Committee for Medicinal Products for Human Use (CHMP),
the scientific committee of the European Medicines Agency (EMEA), granted a
positive opinion recommending approval of HUMIRA(R) (adalimumab) for the
treatment of severe active ankylosing spondylitis. The positive opinion is
based on results from the Adalimumab Trial Evaluating Long-Term Efficacy
and Safety in AS (ATLAS) Phase III clinical trial. In October 2005, Abbott
submitted a supplemental Biologics License Application (sBLA) with the U.S.
Food and Drug Administration (FDA) seeking approval to market HUMIRA as a
treatment for AS.
Ankylosing spondylitis (AS) is a chronic disease of the axial skeleton
and large peripheral joints that causes inflammatory back pain and
stiffness but is also associated with other inflammatory diseases of the
skin and intestines. 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 often is an overlooked cause
of persistent back pain in young adults. In its severe form, AS over time
can result in complete spinal fusion, causing extreme physical limitation.
It is estimated that nearly three million people in Europe are affected by
a spondyloarthritis, such as AS.
"The positive opinion is encouraging news for European ankylosing
spondylitis patients because it signals that a new treatment option will
soon be available to address the symptoms of the disease," said Desiree van
der Heijde, M.D., co-lead investigator of ATLAS and Professor of
Rheumatology at the Maastricht University, The Netherlands.
The European Commission is expected to issue a decision granting the
marketing authorization for HUMIRA as a treatment of AS in the European
Union within approximately 60 days.
Highlights of the ATLAS Study
Ankylosing spondylitis patients (n = 315), who had an inadequate
response to at least one nonsteroidal anti-inflammatory drug (NSAID) or
disease- modifying antirheumatic drug (DMARD), were randomized to receive
either placebo or HUMIRA 40 mg subcutaneously every other week for 24
weeks. Results recorded after 12 weeks and 24 weeks of treatment showed
that HUMIRA significantly reduced signs and symptoms (the study's primary
endpoint), including pain and inflammation, in patients with severe active
AS. Findings also indicated HUMIRA reduced disease activity, induced
partial remission, improved physical function and improved physical quality
of life.
ATLAS study data showed that 58 percent of the trial participants
receiving HUMIRA therapy achieved and sustained at least a 20 percent
reduction in signs and symptoms of pain and inflammation at 12 weeks (ASAS
20, one of the study's primary endpoints). Responses were measured using
the ASsessment in AS (ASAS) International Working Group criteria, which
evaluate four primary parameters: function, pain, patient's global
assessment, and inflammation.
At week 24, 42 percent of patients treated with HUMIRA, compared to 16
percent of patients taking placebo, achieved at least a 50 percent
reduction of disease activity as measured by the Bath Ankylosing
Spondylitis Disease Activity Index (BASDAI), a patient-assessed composite
index of disease activity measuring pain, stiffness and fatigue. Also at
week 24, approximately one out of five patients achieved partial remission
(defined as a value 1/100 and 1/10 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.
Physicians should exercise caution when using HUMIRA in patients who
have heart failure and monitor them carefully. In clinical studies with
another TNF antagonist, a higher rate of serious congestive heart failure
(CHF) related adverse events including worsening CHF and new onset CHF have
been reported. Cases of worsening CHF have also been reported in patients
receiving HUMIRA.
About HUMIRA
Rheumatoid Arthritis:
HUMIRA, in combination with methotrexate, is indicated for the
treatment of moderate to severe, active rheumatoid arthritis in adult
patients when the response to disease-modifying antirheumatic drugs
including methotrexate has been inadequate as well as for the treatment of
severe, active and progressive rheumatoid arthritis in adults not
previously treated with methotrexate.
HUMIRA can be given as monotherapy in case of intolerance to
methotrexate or when continued treatment of methotrexate is inappropriate.
HUMIRA has been shown to reduce the rate of progression of joint damage
as measured by X-ray and to improve physical function when given in
combination with methotrexate.
Psoriatic Arthritis:
HUMIRA is indicated for the treatment of active and progressive
psoriatic arthritis in adults when the response to previous
disease-modifying antirheumatic drug therapy has been inadequate.
To date, HUMIRA has been approved in 65 countries and prescribed to
more than 150,000 patients worldwide. Clinical trials are currently
underway evaluating the potential of HUMIRA in other autoimmune diseases.
Abbott is a global, broad-based health care company devoted to the
discovery, development, manufacture and marketing of pharmaceuticals and
medical products, including nutritionals, device and diagnostics. The
company employs 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 abbott.
View drug information on Humira.
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