Celgene's Revlimid Serves as Precedent for Tysabri Delay Concerns
This article was originally published in RPM Report
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.
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The market resurrection of Tysabri demonstrates the power of risk management but raises a tough question: how far can FDA and industry go into the practice of medicine? Biogen Idec declare they are nt trying to tell doctors how to practice. The strict rules of the risk management plan suggest otherwise.
Tysabri was a sure-fire blockbuster before its withdrawal. Expectations are still high now that it's been given a second chance.
Biogen Idec brilliantly convinced FDA's advisory experts to let the multiple sclerosis drug back on the market. FDA and the drug industry should prepare for the worst. One projection has 100,000 patients eligible for the immunosuppressant once it returns to the market. If there's significant penetration of that population, the drug's discoverer says it could be the setting for a public health disaster.