BioMS says its lead drug has received a fast-track designation from the FDA

Sep
04 2008

Category: MS



bioms-says-its-lead-drug-has-received-a-fast-track-designation-from-the-fda

Drug developer BioMS Medical Corp. said Thursday the U.S. Food and Drug Administration had granted its lead multiple sclerosis compound “fast track” status, which may expedite the drug’s review process.

Edmonton-based BioMS’s dirucotide drug treats secondary progressive multiple sclerosis and is being evaluated in a phase 3 trial with 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.

It can potentially facilitate development and expedite the review process.

“Our receipt of fast track designation for dirucotide in the U.S. is a significant milestone for both BioMS Medical and the MS community,” stated CEO KevinGiese, President and CEO of BioMS Medical.

“We believe dirucotide is well-positioned to become a first-in-class treatment for secondary progressive MS patients, a large patient population with very limited treatment options.”

Source: Whistlerquestion


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