Tysabri (natalizumab)
General Information About TYSABRI®
TYSABRI is approved in more than 40 countries. In the U.S., it is approved for relapsing forms of MS and in the European Union for relapsing-remitting MS. 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 is redefining success in the treatment of MS. In post-hoc analyses of the Phase III AFFIRM trial and as published in The Lancet Neurology, 37 percent of TYSBARI-treated patients remained free of their MS activity, compared to seven percent of placebo-treated patients. In addition, data has been presented showing that treatment with TYSABRI significantly increased the probability of sustained improvement in disability in patients with a baseline expanded disability status scale (EDSS) score ≥ 2.0 by 69 percent relative to placebo.
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 approved in more than 40 countries. In the U.S., it is approved for relapsing forms of MS and in the European Union for relapsing-remitting MS. 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 is redefining success in the treatment of MS. In post-hoc analyses of the Phase III AFFIRM trial and as published in The Lancet Neurology, 37 percent of TYSBARI-treated patients remained free of their MS activity, compared to seven percent of placebo-treated patients. In addition, data has been presented showing that treatment with TYSABRI significantly increased the probability of sustained improvement in disability in patients with a baseline expanded disability status scale (EDSS) score ≥ 2.0 by 69 percent relative to placebo.
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.
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