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This excerpt taken from the ELN 6-K filed Oct 19, 2009. (natalizumab)
In early
2008, TYSABRI was approved in the U.S. to induce and maintain clinical response
and remission in adult patients with moderately to severely active Crohn's
disease (CD) with evidence of inflammation who have had an inadequate response
to, or are unable to tolerate, conventional CD therapies and inhibitors of
TNF-alpha. According to the U.S. full prescribing 2
information,
among patients who responded to TYSABRI in a clinical trial, 54 percent
sustained their response through the one year visit compared to 20 percent of
patients receiving placebo (p<0.001), for a treatment difference of 34
percent.
In the
U.S., TYSABRI is approved for relapsing forms of multiple sclerosis (MS) and in
the European Union for relapsing-remitting MS. TYSABRI is approved
for MS in more than 40 countries. According to data from the Phase
III AFFIRM trial published in the New England Journal of
Medicine, after two years, TYSABRI treatment led to a 68 percent relative
reduction (p<0.001) in the annualized relapse rate, when compared with
placebo, and reduced the relative risk of disability progression by 42-54
percent (p<0.001).
TYSABRI
increases the risk of progressive multifocal leukoencephalopathy (PML), an
opportunistic viral infection of the brain. Other serious adverse
events that have occurred in TYSABRI-treated patients include hypersensitivity
reactions (e.g., anaphylaxis) and infections, including opportunistic and other
atypical infections. Clinically significant liver injury has been
reported in patients treated with TYSABRI in the post-marketing
setting. Common adverse events reported in TYSABRI-treated MS
patients include headache, fatigue, infusion reactions, urinary tract
infections, joint and limb pain and rash.
TYSABRI
is co-marketed by Biogen Idec Inc. and Elan Pharmaceuticals, Inc. For more
information about TYSABRI, please visit www.tysabri.com, www.biogenidec.com or
www.elan.com, or call 1-800-456-2255.
About
Elan
Elan
Corporation, plc is a neuroscience-based biotechnology company committed to
making a difference in the lives of patients and their families by bringing
innovations in science to fill significant unmet medical needs. Elan
shares trade on the New York, London and Dublin Stock Exchanges. For additional
information about the company, please visit www.elan.com.
About
Biogen Idec
Biogen
Idec creates new standards of care in therapeutic areas with high unmet medical
needs. Founded in 1978, Biogen Idec is a global leader in the discovery,
development, manufacturing, and commercialization of innovative therapies.
Patients in more than 90 countries benefit from Biogen Idec's significant
products that address diseases such as lymphoma, multiple sclerosis, and
rheumatoid arthritis. For product labeling, press releases and additional
information about the company, please visit www.biogenidec.com.
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