Biogen Idec, Elan say FDA needs more time to review Tysabri risk plan for multiple sclerosis

By E. Janene Geiss

Philadelphia, March 22 - Biogen Idec and Elan Corp., plc said Wednesday that the Food and Drug Administration informed the companies that the agency will extend its regulatory review of Tysabri (natalizumab) as a treatment for multiple sclerosis by up to 90 days.

The companies said the FDA is requiring additional time to review information regarding the Tysabri risk management plan. Under this revised timeline, the companies anticipate action from the FDA on or before June 28, according to a company news release.

Biogen Idec is a Cambridge, Mass., pharmaceutical company that develops, manufactures and commercializes new therapies for oncology, neurology and immunology.

Elan is a Dublin, Ireland, neuroscience-based biotechnology company committed to bringing innovations in science to fill significant unmet medical needs.

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