Biogen Idec announced that five-year results from the ENDORSE Phase 3 extension study show Tecfidera (dimethyl fumarate) provides strong and sustained efficacy in a broad range of people living with relapsing-remitting multiple sclerosis (RRMS). These data will be presented at the Sixth Triennial Joint Meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis and the European Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS-ECTRIMS).
Across all patients in the ENDORSE study who received Tecfidera, including some patients who were treated for up to seven and a half years, the safety profile remained consistent with no new or worsening safety signals. Additional analyses in patients who were newly diagnosed with multiple sclerosis (MS) when the parent studies DEFINE and CONFIRM began indicate that Tecfidera had a robust long-term effect on MS relapse rates, disability progression and MRI measures in these patients.
“Tecfidera continues to provide patients with effective oral treatment for MS that is supported by a growing body of data reinforcing its benefits and favorable safety profile,” said Alfred Sandrock, group senior vice president and chief medical officer at Biogen Idec. “These new ENDORSE results provide further insight into the positive impact of using Tecfidera early in the course of MS and for long-term treatment of this chronic disease.”
Date: September 11, 2014
Source: Biogen Idec