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Affymax, Inc. Message Board

  • acricketeer acricketeer Feb 25, 2013 7:55 AM Flag

    ELN/BIIB's Tysabri Was Withdrawn over PML Deaths and Reinstated into the Market

    Some may say it's apples and oranges, but both addressed deaths -- not normal safety ocncerns. Yes, there are alternative drugs already on the market. However, this was a voluntarily withdrawal. The FD has not yet withdrawn the license. The drug won't be back on the market for at least a year or more. However, it's possible it could go back on the market it Takeda/AFFY develops a screening test for allergic reactions. ELN developed a screening test for JCV positive virus for those patients who are susceptible to PML. Reinstating a drug that caused fatalities is not unprecedented in recent history. However, they have to develop a roadmap to address these safety concerns.

 
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