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Multiple Sclerosis drug dirucotide (MBP8298) receives fast track designation from FDA
September 04, 2008 07:33

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BioMS Medical Corp. announced that the Food and Drug Administration (FDA) of the United States has granted fast track designation for the Company's lead drug, dirucotide (MBP8298), for the treatment of secondary progressive MS (SPMS). Dirucotide (MBP8298) is currently being evaluated in a U.S. pivotal phase III trial, named MAESTRO-03, at 68 sites with approximately 510 patients.

Fast track designation is an FDA status reserved for products that are intended to treat a serious or life-threatening condition and that demonstrate the potential to address unmet medical needs for that condition. Fast track designation can potentially facilitate development and expedite the review process..............

For the full report please go to MSRC: MS Research News : Drugs : MBP8298 - http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=1308