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Novartis/Mitsubishi Tanabe MS Drug Gets FDA Priority Review

This article was originally published in PharmAsia News

Executive Summary

U.S. FDA granted priority review status to Novartis multiple sclerosis drug Gilenia (oral fingolimod, FTY720). The NDA was accepted by FDA in December and the once-daily Gilenia could become the first approved oral therapy for MS. Licensed from Mitsubishi Tanabe Pharma, the oral fingolimod compound was first developed by Yoshitomi Pharmaceutical (currently Mitsubishi Tanabe), Mitsui Sugar and Kyoto University. (Click here for more - Japanese language



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