By JARED A. FAVOLE
August 26, 2008; Page D2
August 26, 2008; Page D2
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 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 Monday, 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.
The Wall Street Journal
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