MS Drug Tysabri Approved in Canada

U.S. firm Biogen Idec and Irish firm Elan said Wednesday they have been approved to sell multiple-sclerosis drug Tysabri in Canada.

After undergoing priority review, the drug has been cleared for use in patients with relapsing-remitting multiple sclerosis.

Tysabri — the first in a new generation of MS treatments called selective adhesion molecule inhibitors — has been shown to significantly reduce the rate of MS relapses and also slow the progression of MS-related disability.

Tysabri has demonstrated a major reduction in relapses — by more than two-thirds — in clinical trials, said Paul O’Connor, lead investigator of the drug’s AFFIRM study and chief of neurology at St. Michael’s Hospital in Toronto. Clinical trials that have looked at TYSABRI provide us with impressive evidence that it is a highly effective treatment for patients with MS, he said.

Tysabri’s Canadian approval was supported by data from the two-year, 942-patient AFFIRM study that showed a 68-percent reduction in MS relapse rate, compared to placebo, and a 42-percent decrease in disability progression.

Tysabri returned to the U.S. market this year following several months of market suspension after three patients taking the drug contracted a deadly brain infection known as PML.

Earlier this year an advisory panel to the Food and Drug Administration voted that Tysabri sales should resume with a number of restrictions, including that the treatment cannot be prescribed in combination with other MS therapies.