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Results Announced from Phase 3 Trial of a Newly Formulated Tecfidera-like Oral Therapy for Relapsing MS

July 31, 2019

Biogen Inc. and Alkermes plc announced top-line results of a five-week, Phase 3 study that compared gastrointestinal side effects and tolerability of oral Tecfidera® (dimethyl fumarate, Biogen Inc.), a disease-modifying therapy approved for relapsing forms of MS, with a newly formulated, related oral compound called diroximel fumarate.
  • According to a press release, diroximel fumarate was better tolerated and had significantly fewer reported gastrointestinal symptoms compared to Tecfidera.
  • The most common adverse events for both treatment groups were flushing, diarrhea and nausea. Rates of these events were significantly lower for the diroximel fumarate group and fewer people on diroximel fumarate dropped out of the study due to side effects.
  • The companies have submitted diroximel fumarate for approval to the U.S. Food and Drug Administration under a regulatory pathway that relies on the original clinical trial results that led to the agency’s 2013 approval of Tecfidera as a disease-modifying therapy for relapsing forms of MS.

About Multiple Sclerosis

Multiple sclerosis is an unpredictable, often disabling disease of the central nervous system. Symptoms range from numbness and tingling to blindness and paralysis, and there is currently no cure for MS. The progress, severity and specific symptoms of MS in any one person cannot yet be predicted, but advances in research and treatment are leading to better understanding and moving us closer to a world free of MS. An estimated 1 million people live with MS in the United States. Most people with MS are diagnosed between the ages of 20 and 50, and it affects women three times more than men.


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