Tysabri Or Not Tysabri?
This article was originally published in RPM Report
FDA is facing one of its toughest decisions on whether to let Biogen Idec/Elan's multiple sclerosis drug Tysabri back on the market. The agency has just begun its re-review of the supplemental BLA and is in the process of determining whether to grant the application expedited priority review.
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There is no question someone is over-reacting to safety issues with Biogen Idec/Elan's Tysabri and Lilly/Amylin's Byetta. But is it FDA-or investors?
FDA says it needs more time to review an application for the MS drug Tysabri for treatment of Crohn's Disease. Investors worry the delay may be a red flag of safety issues related to the new indication. Recent history with more complex risk plans indicates Wall Street may be getting worked up over nothing.
Risk management plans are an increasingly common feature of new drug approvals, and Congress seems set on making them a standard part of the FDA review process. Industry seems willing to go along, accepting some more restricitions on new products in exchange for restoring confidence in drug safety. There is only one problem: FDA is not so sure this is a great idea.