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.
Multiple sclerosis is an unpredictable disease of the central nervous system. Currently there is no cure. Symptoms vary from person to person and may include disabling fatigue, mobility challenges, cognitive changes, and vision issues. An estimated 1 million people live with MS in the United States. Early diagnosis and treatment are critical to minimize disability. Significant progress is being made to achieve a world free of MS.