Results from a five-year study on US biotech firm Biogen Idec’s (Nasdaq: BIIB) Tecfidera (dimethyl fumarate) show strong and sustained efficacy in a broad range of patients living with relapsing-remitting multiple sclerosis.
At five years, interim results show that patients who continued on Tecfidera experienced sustained clinical efficacy on relapse and disability progression endpoints as measured by annualized relapse rate and 24-week expanded disability status scale, similar to what was observed after two years in initial studies. The patients maintained a low frequency of brain lesions over five years as measured by new or enlarging T2-hyperintense lesions, new non-enhancing T1-hypointense lesions and gadolinium-enhanced lesions.
The safety profile remained consistent with no new or worsening safety signals across all patients in the study, including some patients who received Tecfidera for up to seven and a half years.
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