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FDA Agrees to Fast Review for Drug Being Tested for MS

FDA Agrees to Fast Review for Drug Being Tested for MS

It was announced by the drug maker BioMS Medical Corp. (Edmonton, Alberta) that dirucotide (also known as MBP8298) has been designated by the U.S. Food and Drug Administration as a “Fast Track Product.” This designation should expedite its future review by the FDA after the sponsor submits results of current trials now underway.

Dirucotide is a synthetic fragment of myelin basic protein (MBP, a component of myelin), which reduces the production of spinal fluid antibodies that react against MBP during the immune attack on the brain and spinal cord that occurs in MS. The drug, which is delivered intravenously, is currently under study in two studies in secondary-progressive MS (510 people in the U.S., and 611 people in Europe) and one study in 218 people with relapsing-remitting MS. All studies are fully enrolled.

An earlier study of dirucotide showed a statistically significant delay in clinical progression among individuals with certain genetically determined “HLA” types; HLA is a molecular tag located on body cells that helps the immune system attack foreign invaders and, in the case of autoimmune diseases, the body’s own tissues. This study wasreportedat the AAN in 2006.