ELN/BIIB's Tysabri Was Withdrawn over PML Deaths and Reinstated into the Market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 The FD has not yet withdrawn the license.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.