Tysabri still on hold

April 3, 2006

Just when Biogen Idec and Elan were hoping for the red light to turn green, it changed to yellow instead, as the FDA announced it would wait up to another 90 days before giving its final decision on the reintroduction of natalizumab (Tysabri). According to the FDA, extensions such as this often occur after a manufacturer submits a major amendment to the existing application, requiring extra time for the agency to review.

Tysabri still on hold

Just when Biogen Idec and Elan were hoping for the red light to turn green, it changed to yellow instead, as the FDA announced it would wait up to another 90 days before giving its final decision on the reintroduction of natalizumab (Tysabri). According to the FDA, extensions such as this often occur after a manufacturer submits a major amendment to the existing application, requiring extra time for the agency to review. The new submission for the multiple sclerosis drug contains a revised risk management plan addressing the safety issues discussed at a meeting of the Peripheral and Central Nervous System Drugs Advisory Committee on March 7 and 8. The agency said the application is a high priority and it will attempt to complete the final review before the end of the 90-day period.

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