Biogen presents data showing sustained efficacy, long-term safety of Tecfidera
Data presented shows that Biogen Idec's Tecfidera continues to offer consistent and strong efficacy combined with a favorable safety profile in a broad range of patients with relapsing-remitting multiple sclerosis, or RRMS, including those patients who are newly diagnosed with the disease. Interim analyses from the ENDORSE long-term extension study show that Tecfidera maintained its effect in reducing disease activity in patients treated for four years. No new or worsening safety signals were observed in patients who had received Tecfidera for up to six and a half years. In addition, a separate post-hoc analysis of the Phase 3 DEFINE and CONFIRM clinical trials shows that Tecfidera significantly reduced multiple sclerosis relapses in treatment-naïve patients, while delaying the overall progression of the disease over time.