HEALTH CANADA APPROVES BIOGEN, ELAN'S TYSABRI

Biogen Idec Canada and Elan have announced that, following a priority review process, Health Canada has granted approval to Tysabri (natalizumab) for the treatment of relapsing-remitting multiple sclerosis (MS). Tysabri is the first in a new therapeutic class of MS treatments (called selective adhesion molecule inhibitors) and has been shown to significantly reduce the rate of MS relapses as well as the progression of disability.

A two-year, randomized, multicenter, placebo-controlled, double-blind study (called AFFIRM) enrolled 942 patients and evaluated the effect of Tysabri on the rate of clinical relapses and the progression of disability. The results showed that Tysabri reduced the rate of clinical relapses by 68 percent relative to placebo and the risk of sustained disability progression associated with MS by 42 percent relative to placebo. Treatment with Tysabri also resulted in sustained and statistically significant reductions in brain lesion activity as measured by magnetic resonance imaging (MRI) scans.

In Canada, Tysabri is indicated as monotherapy (i.e. a single disease-modifying agent) for the treatment of patients with the relapsing-remitting form of MS to reduce the frequency of clinical relapses, to delay the progression of disability and to decrease the number and volume of active brain lesions identified on magnetic resonance imaging (MRI) scans. The drug is administered once every four weeks by intravenous infusion.