If you thought the road back for Tysabri would be a relatively simple one after the successful advisory committee meeting last minute, you would be wrong-- which is what one would expect when dealing with the "drama queen" of Multiple Sclerosis therapies. On Wednesday morning, the United States Food and Drug Administration extended its review of Tysabri by an additional 90 days, moving the date for a decision on reapproval out to sometime on or before June 28, 2006.
"The companies have been informed by the FDA that the Agency requires additional time to review information regarding the Tysabri risk management plan," Tysabri creators Biogen and Elan noted in a joint statement.
This is a not altogether surprising development and does not seem to jeopardize the return of the drug in any way. 90 days seems like a long time, but it is actually the minimum amount of time the FDA will grant for extensions in these circumstances-- in other words, they may not need the full amount of time. Furthermore, it seems quite ambitious in retrospect for a governmental agency to finalize a complex and critical risk management plan in the mere three weeks between the advisory committee meeting and the previous committed decision date of March-end.
In short, with this move the FDA has certainly delayed Tysabri's re-introduction to market, but this delay does not seem to be a point of concern in terms of the FDA preventing the drug from coming back altogether.
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