ENDORSE is a global, dose-blind extension study evaluating the long-term safety and efficacy of Tecfidera 240mg, dosed twice a day (BID) or three times a day (TID). Patients who received up to two years of Tecfidera in the Phase 3 DEFINE and CONFIRM studies continued on the same dose in ENDORSE. Patients who previously received placebo or glatiramer acetate (GA; 20mg subcutaneous daily injection; CONFIRM only) in DEFINE and CONFIRM were randomized 1:1 to Tecfidera BID or TID. Patients participating in ENDORSE will be followed for up to eight years. The primary objective of the study is to evaluate the long-term safety profile of Tecfidera.
The safety profile remained consistent across all patients in the ENDORSE study who received Tecfidera with no new or worsening safety signals. At five years (two years in DEFINE or CONFIRM and three years in ENDORSE), interim results show that patients who continued on Tecfidera BID treatment experienced sustained clinical efficacy on relapse and disability progression endpoints as measured by annualized relapse rate (ARR) and 24-week Expanded Disability Status Scale (EDSS), similar to what was observed after two years in DEFINE and CONFIRM. These patients also 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 [Gd+] lesions.
Tecfidera is already approved for the treatment of patients with relapsing forms of multiple sclerosis.
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