- Interim Results from ENDORSE Extension Study Reinforce Favorable Safety Profile in Patients Treated for Up to Six and a Half Years
- Analysis of Treatment-Naïve MS Patients Shows Positive Treatment Effects on Relapses, Disability Progression and MRI Outcomes
Because MS is a chronic, life-long disease, physicians and patients need to know they are taking a treatment that will offer them sustained efficacy over the long-term with a consistent safety profile,said Doug Williams, executive vice president, Research and Development, Biogen Idec.
These analyses provide important information on the benefits of TECFIDERA’s strong efficacy and favorable safety for a wide range of patients with RRMS – from those treating their MS for the first time to those who have been on TECFIDERA treatment for up to six and a half years.
ENDORSE is a global, dose-blind extension study to determine the long-term safety and efficacy of TECFIDERA (240 mg, dosed twice a day (BID) or three times a day (TID)). Patients who received two years of TECFIDERA in DEFINE and CONFIRM continued on the same dose in ENDORSE. Patients who previously received placebo or glatiramer acetate (GA; 20 mg subcutaneous daily injection; CONFIRM only) in DEFINE or CONFIRM were randomized 1:1 to TECFIDERA BID or TID. All currently enrolled patients included in the interim analyses had completed four years in the TECFIDERA clinical program (two years in DEFINE or CONFIRM plus two years in ENDORSE). At present, some patients have received TECFIDERA treatment for up to six and a half years.
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