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Article: Biogen, Elan Again Put Fate Of Tysabri Into FDA's Hands.
- Article from:
- BIOWORLD Today
- Article date:
- November 3, 2009
CopyrightCOPYRIGHT 2009 A Thomson Healthcare Company. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Washington Editor
The FDA now finds itself in an unenviable position, after receiving an application to clear Tysabri (natalizumab) again, seven months after the multiple sclerosis product was pulled from the market following its links to two fatalities, despite showing clinical efficacy.
And many industry observers expect the agency's risk-benefit analysis to come under scrutiny as the review process moves forward.
"I think they're bound to hold an advisory panel meeting, because these are the exact types of issues you'd want in a public forum," said Elise Wang, an analyst with Citigroup. "And I think there will be a tug of war, with us hearing ...
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