FDA Panel Votes in Favor of Biogen’s Tysabri for Crohn’s Disease

8/1/07

Despite numerous gloomy predictions in the media over the last few days, a joint meeting of two FDA advisory committees went well for Biogen Idec (BIIB) yesterday. The panel voted 12-to-3 in favor of recommending that Tysabri (natalizumab)—codeveloped with Elan and already approved for multiple sclerosis—be approved for treating moderate-to-severe Crohn’s disease in patients for whom other treatments don’t work or are intolerable. Though a final decision by the FDA is still weeks away, the agency usually follows the recommendations of its panels.

A briefing document posted by the FDA ahead of the meeting, combined with a recent European decision not to approve the drug for Crohn’s disease, prompted many industry observers to predict that yesterday’s vote would go the other way. But a couple of us from Xconomy happened to be visiting Biogen headquarters yesterday afternoon and noticed that internally the mood was more optimistic, if cautiously so.

Tim Hunt, Biogen vice president of public affairs, said that the FDA briefing documents always give plenty of fodder for negative predictions, and that Biogen and Elan weren’t reading too much into this one. Hunt painted an amusing picture of the companies’ SWAT-team-like effort to dissect the document and pull together hundreds of PowerPoint slides addressing any possible questions or criticisms the panel might raise during its deliberations—and then to beam the appropriate slides to the companies’ representatives as needed during the meeting. Evidently, the effort succeeded.

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