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Health Canada Approves Promising New Drug to Treat Multiple Sclerosis

Posted on: Wednesday, 4 October 2006, 15:00 CDT

TORONTO (CP) - Canadians with multiple sclerosis will soon have access to a promising new drug for the treatment of the relapsing-remitting form of the progressive disease, its manufacturer announced Wednesday.

Biogen Idec Canada and Elan Corp. said Health Canada has approved Tysabri (natalizumab), the first in a new therapeutic class of MS treatments called selective adhesion molecule inhibitors.

In an international clinical trial that included Canadians afflicted with MS, the medication was found to reduce the rate of relapse by 68 per cent compared with placebo and the risk of sustained disability progression by 42 per cent.

Use of the drug also reduced development of brain lesions, an effect of the disease that occurs when normally disease-fighting white blood cells attack the myelin sheathing that protects nerve cells in the brain, spinal cord, the eyes and elsewhere in the body.

An estimated 55,000 to 75,000 Canadians have multiple sclerosis, a progressive neurodegenerative disease that can lead to severe disability. About three-quarters have the relapsing-remitting form of the disease.

The newly approved compound works by preventing the body's affected immune cells from migrating from the bloodstream into the brain, where they can cause inflammation and damage to nerve fibres and their myelin coating.

"Tysabri has demonstrated a major reduction in relapses by more than two-thirds in clinical trials," said Dr. Paul O'Connor, lead investigator for the two-year clinical trial and head 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."

But the drug, which is administered intravenously once a month, is not without its risks. It was approved in the United States in late 2004, then withdrawn from the market by its maker after two people on the medication died from a rare brain infection.

The Food and Drug Administration allowed Tysabri back on the U.S. market under certain restrictions, including a requirement that it not be taken with other MS drugs containing interferon. In Canada, Tysabri is also approved as a single therapy.

"Canada has one of the highest rates of MS in the world," said Deanna Groetzinger, vice-president of government relations and policy at the Multiple Sclerosis Society of Canada. "We are pleased there is another approved treatment option for Canadians with relapsing-remitting MS."

Source: Canadian Press

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