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Tysabri to Get Review in March

An FDA panel will review the application from Biogen and Elan March 7.
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Biogen Idec

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said the Food and Drug Administration's Peripheral and Central Nervous System Drugs Advisory Committee will review their resubmission for the multiple sclerosis drug Tysabri on March 7.

The drug was pulled from the market early last year after being linked to a potentially fatal brain disease called progressive multifocal leukoencephalopathy. On Sept. 26, the companies submitted a supplemental biologics license application to the FDA in hopes of getting the drug back on the market.

The FDA granted the Tysabri application priority review, a status given to products that are considered to be potentially significant advancements over existing therapies and that address an unmet medical need. Biogen and Elan expect the FDA to make a determination on the application by late March.

Biogen and Elan recently completed a comprehensive safety evaluation of more than 3,000 Tysabri patients in collaboration with leading experts in PML and MS. The results yielded no new confirmed cases of PML beyond the three that have been previously reported.

Shares of Biogen were up 69 cents to $45.62 in premarket trading Monday. Elan was gaining 23 cents at $13.89.