Biogen Idec is scheduled to present the latest efficacy and safety profile updates on TECFIDERA (dimethyl fumarate), its lead treatment for relapsing-remitting multiple sclerosis (RRMS), during the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) happening now in Barcelona, Spain until October 10, 2015. The company will be discussing the drug’s benefits in reducing relapses and slowing progression of disabilities in patients who are still in the early phase of the disease, and will also show that TECFIDERA has a sustained efficacy of up to 6 years.
Biogen will also present a post-hoc analysis of TECFIDERA’s enhanced ability to reduce RRMS-related inflammatory activity, compared to glatiramer acetate (GA). Results of the ENDORSE study and how the drug was able to demonstrate a positive benefit-risk profile for up to 6 years of follow-up will also be presented.
“The benefits of taking a strong, efficacious therapy early in the disease course have been shown to improve a patient’s long-term prognosis when treatment is initiated before MS has advanced and caused irreparable damage,” said Ralf Gold, M.D., professor and chair of the Department of Neurology, St. Josef-Hospital/Ruhr-University Bochum in a press release. “The data at ECTRIMS demonstrate that patients initiating treatment with TECFIDERA early in their disease experienced significant reductions in relapse rates and disability progression over time compared to those taking placebo.”
“Data continue to demonstrate that TECFIDERA reduces disability and relapse activity early in the disease course – meaning that it can help slow the progression of this debilitating disease, which is particularly important in newly-diagnosed or early disease course patients,” said Gilmore O’Neill, M.D., vice president of Multiple Sclerosis Research and Development at Biogen. “With more than six years of clinical data supporting its strong, sustained efficacy and well-established safety profile, TECFIDERA has been used by more than 170,000 patients worldwide, making it the most-prescribed oral MS medication globally.”
According to the press release, Biogen’s scheduled presentations during this year’s ECTRIMS are as follows:
- Efficacy of Delayed-Release Dimethyl Fumarate in Early Multiple Sclerosis: Post-Hoc Analysis of the Phase 3 DEFINE and CONFIRM Studies According to Baseline Disability – Poster P565 – Thursday, 8 October – 15:45-17:00 CEST
- Longer-Term Follow-Up of the Efficacy of Delayed-Release Dimethyl Fumarate in Newly Diagnosed Patients with RRMS: An Integrated Analysis of DEFINE, CONFIRM, and ENDORSE – Poster P564 – Thursday, 8 October – 15:45-17:00 CEST
- Long-Term Follow-Up of the Safety of Delayed-Release Dimethyl Fumarate in RRMS: Interim Results from the ENDORSE Extension Study – Poster P544 – Thursday, 8 October – 15:45-17:00 CEST
- Efficacy of Delayed-Release Dimethyl Fumarate Versus Glatiramer Acetate on a Novel Composite Outcome Measure of Inflammatory Disease Activity: Post-Hoc Analysis of the CONFIRM Study – Poster P1063 – Friday, 9 October – 15:30-17:00 CEST
TECFIDERA is taken orally, and the initial recommended dose is 120 mg twice a day for a total of 240 mg per day for seven days. After seven days, the usual dose of TECFIDERA is two 240 mg capsules taken daily, for a total of 480 mg per day.
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