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New Data Shows Tecfidera is Strong in Treating RRMS

October 8, 2015

American biotechnology company Biogen will present new data that reinforce the effectiveness and well-established safety profile of Tecfidera in a broad range of patients suffering from relapsing-remitting multiple sclerosis (RRMS) at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis in Barcelona, Spain this weekend. The data clearly shows that Tecfidera significantly reduced MS relapses and delayed disability progression in patients who are newly diagnosed and those early in their disease course. These effects were sustained over six years of follow-up care.
The presentation will show post-hoc analysis, in which Tecfidera significantly reduced key inflammatory disease outcomes as compared to glatiramer acetate. Results show that a higher proportion of TECFIDERA patients were free of inflammatory disease activity at all time intervals over two years:

  • 36 percent of TECFIDERA patients compared to 29 percent of GA patients during weeks 0–24
  • 34 percent of TECFIDERA patients compared to 23 percent of GA patients during weeks 24–48
  • 21 percent of TECFIDERA patients compared to 16 percent of GA patients during weeks 48–96

“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. “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.”
TECFIDERA is an oral therapy for relapsing forms of MS, including relapsing-remitting MS, the most common form of MS. TECFIDERA is currently approved in the United States, the European Union, Canada, Australia and Switzerland. Through a robust clinical trial program and commercial launches starting with the United States in March 2013, more than 170,000 patients have been treated with TECFIDERA worldwide.

TECFIDERA has been proven to reduce rate of MS relapses, slow the progression of disability, and the number of MS brain lesions, while demonstrating a favorable benefit-risk profile in a broad range of patients with relapsing forms of MS. In clinical trials, the most common adverse events associated with TECFIDERA were flushing and gastrointestinal events. Other side effects included a decrease in mean lymphocyte counts during the first year of treatment, which then plateaued. TECFIDERA is contraindicated in patients with a known hypersensitivity to dimethyl fumarate or any of the excipients of TECFIDERA. Rare cases of progressive multifocal leukoencephalopathy (PML) have been seen with TECFIDERA patients in the setting of severe and prolonged lymphopenia.