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4/27/10Gilenia and fingolimod are the same thing, the Novartis drug FTY720
(Posted By: Josi Creek)
I finally have clarity around a befuddling conversation that I had with an acquaintance with MS who said that her neurologist was going to start her on the new oral drug that was probably going to be available this summer. "What, fingolimod?" I asked. "No, I would have remembered that weird name. Something else that starts with a 'g,' I think," she replied. "He thought it wouldn't be ready so soon, but now there is news that it might be coming in June. He heard it at the big neurology meeting from 'sources.'" Here is the deal: Gilenia and fingolimod are the same thing, the Novartis drug FTY720. I guess the name "fingolimod" was just not flying with the marketing department. In late February, the FDA granted "priority review" status to Gilenia. The FDA grants priority review status to drugs that could have a much better efficacy or fewer side effects than existing drugs or to drugs for conditions where no adequate therapy exists. This status reduces the review period from 10 months to 6 months. However, Gilenia contains a new active ingredient, so this actually might get extended as the FDA is likely to require an Advisory Committee meeting to evaluate the risk management program. However, it looks like real progress is being made and I estimate that, if all goes according to plan, this drug will be to market before the end of 2010. Labels: Fingolimod. Oral Disease Modifying Drugs |
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