By Julie Donnelly, Boston Business Journal
Biogen Idec (NASDAQ: BIIB) is awaiting approval from the U.S. Food and Drug Administration for its first oral multiple sclerosis therapy, and has released new Phase 3 data that shows positive efficacy and safety for the drug candidate. The FDA is scheduled to make a decision on or before Dec. 28. The Weston, Mass-based biotechnology company released pooled data from two Phase 3 studies which showed statistically significant and clinically relevant effects in reducing multiple sclerosis (MS) relapses and progression of disability, as well as reductions in magnetic resonance imaging (MRI) measures of disease activity. The data also showed that continued use of the drug candidate generally did not result in any new or worsening side effects“These data provide additional insight into the positive efficacy and safety results from our Phase 3 studies, showing there is a consistent beneficial effect with dimethyl fumarate in reducing MS relapses, brain lesions and disability,” Dr. Alfred Sandrock, chief medical officer of Biogen Idec, said in a statement. “If approved, dimethyl fumarate may provide a broad range of MS patients with an effective therapy that offers the ease of oral administration and an acceptable tolerability profile.”
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