BioMS Medical Corp Announces FDA Grants Fast-Track Status for MS Experimental DrugCanada´s BioMS Medical Corp announced its lead experimental drug for the treatment of multiple sclerosis dirucotide (MBP8298) was granted fast-track status by the U.S. Food and Drug Administration.
09-04-2008 |
11:26 hs.
Author: Cate Kirby
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The Food and Drug Administration (FDA) has granted Canadian biotech BioMS Medical Corp´s experimental drug dirucotide – also called MBP8298 - for the treatment of secondary progressive multiple scelerosis (SPMS) a fast-track designation, which could help develop and speed the review process. Dirucotide is currently being evaluated in a U.S. Phase 3 trial, named MAESTRO-03 at 68 sites with approximately 510 patients. The drug was licensed globally by Eli Lilly & Co in December 2007, in a deal for $ 87 million dollars cash, and if the drug is approved and proves successful, up to $ 410 million dollars including royalties and fees. Publish comment:
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