FDA to extend review of Tysarbi

The Food and Drug Administration has told Elan and Biogen Idec that they will extend its regulatory review of Tysarbi as a treatment for Crohn’s diseases by up to three months.

Both companies were informed by the FDA that they need additional time to review information regarding Tysarbi’s risk management plan for Crohn’s disease. The three-month period should end on Jan. 13, 2008.

Approximately one million people worldwide have Crohn’s disease, a chronic and progressive inflammatory disease of the gastrointestinal tract, which commonly affects both men and women.

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