Biogen’s diroximel fumarate impresses at Phase 3 in relapsing multiple sclerosis
pharmafile | May 31, 2019 | News story | Medical Communications, Research and Development | Biogen, diroximel fumarate, multiple sclerosis, pharma, relapsingg multiple sclerosis
New data for Biogen’s investigational therapy diroximel fumarate has been revealed at the Consortium of Multiple Sclerosis Centers (CMSC) in Seattle, supporting its safety and efficacy in the treatment of relapsing multiple sclerosis.
During interim analysis of 696 patients as part of an ongoing Phase 3 study. In a sub-group analysing patients naive to prior disease-modifying therapy treatment or those previously treated with an interferon (IFN) or glatiramer acetate (GA), the therapy showed “significant improvements” in radiological and clinical endpoints from baseline after one year of treatment; it was found that adjusted annualised relapse rate fell by 72% from baseline after 48 weeks in this group.
It was also found that the drug led to 64% reductions in the average number of gadolinium-enhancing (Gd+) lesions compared to baseline, while 89% achieved no Gd+ lesions after 48 weeks, compared to 74% at baseline.
“The results we are presenting at CMSC add to the body of evidence supporting the tolerability of diroximel fumarate and its potential effectiveness in relapsing MS patient populations, including newly diagnosed and early switch patients,” said Michael Ehlers, Executive Vice President, Research & Development at Biogen. “We are excited about these data for diroximel fumarate and believe this distinct oral fumarate has the potential to be a meaningful treatment option for people living with MS.”
Developed in partnership with Alkermes, the therapy is currently under review by the FDA, with a decision expected by the end of the year.
Matt Fellows
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