Two phase 3 clinical trials have shown that oral doses of a drug called BG-12 show "significant" and "clinically meaningful" reductions in multiple sclerosis (MS) relapses and brain lesions in people with a relapsing form of MS.
The active ingredient in BG-12 is the compound dimethyl fumarate. The trials, which were published yesterday in the New England Journal of Medicine, were financed by Biogne Idec, a biotechnology company that creates drugs for neurological and autoimmune disorders. The company is seeking U.S. Food and Drug Administration (FDA) approval for the treatment.
“The publication of both dimethyl fumarate pivotal studies in NEJM is another achievement for this important investigational therapy,” said Dr. Katherine Dawson, senior medical director at Biogen Idec Neurology Research and Development and co-author of the published studies. “The data from its clinical development program consistently indicate that dimethyl fumarate may provide tangible benefits and address existing treatment needs of people living with MS. We are working closely with regulatory authorities across the globe with the aim of making the review of dimethyl fumarate as quick as possible.”
The two studies found that both twice-a-day and thrice-a-day 240mg treatments with BG-12 reduced the proportion of patients with relapsing-remitting MS who relapsed by anywhere from 44% to 51%. Both studies were two-year global clinical trials that investigated BG-12 compared to a placebo.
Just last week, a once-a-day pill for the treatment of relapsing forms of MS called Aubagio was approved by the FDA.