Expedited decision on Tysabri?

Executive Summary

FDA says it is trying to complete its review of Biogen Idec/Elan's Tysabri before the new June 28, 2006 review deadline. Natalizumab's user fee date is being extended 90 days to review changes to the drug's risk management plan. The Tysabri application is a "high priority" and FDA is "working intensively to complete review of this new information and will attempt to do so before the end of the 90-day extension period," the agency says. Re-launch of the multiple sclerosis drug is now slated for the third quarter...