FDA fast tracks Canadian MS drug
EDMONTON, Canada The Food and Drug Administration has given fast-track designation to a multiple sclerosis drug by BioMS Medical, a company based in Edmonton, Alberta.
The drug, dirucotide, is undergoing phase III testing in a 510-patient trial. Phase II trials showed that the drug delayed progression of the disease for five years.
The FDA grants fast-track status to products with a potential to unmet needs in patients with particularly serious diseases, which can expedite regulatory approval.