Company, FDA changing label on MS drug

From The Wall Street Journal August 26:

Biogen Idec Inc. and Elan Corp. are working with the U.S. Food and Drug Administration to amend the label for the multiple-sclerosis drug Tysabri after two patients in Europe got a serious brain disorder while taking it.

The FDA is working with the companies to amend the product labeling to inform patients of the two cases. A company spokeswoman said the updated label will be based on the two cases, which the company had confirmed in late July.

The patients had been taking the drug, as a sole treatment for multiple sclerosis, for more than a year, according to an alert the FDA issued to health-care professionals that was posted on the agency's Web site Aug. 25.

The drug is available in the U.S. only to patients with elapsing multiple sclerosis or Crohn's disease who are enrolled in a risk-minimization plan, under which every patient is closely monitored for serious infections.

The FDA said it still believes Tysabri, taken alone, may confer a lower risk of the brain disorder progressive multifocal leukoencephalopathy than when it is used in combination with other treatments.

Following the FDA posting the notice on its Web site late Aug. 25, shares of Biogen rose about 2%, closing at $53.48, and Elan gained close to 5%, closing at $14.25. In after-hours trading, Biogen shares rose to $53.51, while those of Elan increased to $14.47.