Experimental Multiple Sclerosis Drug Shows Promise

Tecfidera reduces annualized MS relapse rate by 63% compared with placebo.

Biogen is set to present data that reinforces the proven efficacy and safety profile of Tecfidera in a wide variety of relapsing-remitting multiple sclerosis (RRMS) patients at the 31^st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Barcelona, Spain.

ECTRIMS takes place from October 7 to October 10, 2015. The data shows that Tecfidera effectively reduced relapses in RRMS patients and delays disability progression in newly diagnosed patients or patients who were early on in their disease course.

New data at ECTRIMS also includes a post-hoc analysis, in which Tecfidera was found to significantly reduce key inflammatory disease outcomes compared with glatiramer acetate (GA). In a separate analysis, Tecfidera demonstrated a favorable benefit-risk profile throughout 6 years of follow-up from the ENDORSE study.

“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, MD, 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.”

When analyzing the phase 3 DEFINE and CONFIRM studies, it became clear that Tecfidera had significant effects on clinical outcomes in RRMS patients, with the drug reducing annualized relapse rate (ARR) by 63% compared with those in the placebo group. The drug also reduced the risk of 12-week confirmed disability progression by 40%.

A post-hoc analysis of the MRI population from the phase 3 CONFIRM study found that Tecfidera significantly reduced key inflammatory disease outcomes compared with GA. The CONFIRM study investigated Tecfidera against a placebo group, as well as GA against a placebo group.

The analysis yielded results that indicated a higher proportion of Tecfidera patients were free of inflammatory disease activity at all time intervals over a 2-year period.

“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, MD, vice president of Multiple Sclerosis Research and Development at Biogen. “With more than 6 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.”

A 6-year follow-up of the data from the DEFINE, CONFIRM, and ENDORSE studies show long-term treatment with Tecfidera results in strong and sustained effects on relapses and disability progression in newly-diagnosed patients. In patients who switched from placebo to treatment with Tecfidera, the ARR was reduced from 0.26 to 0.10, representing a 61% reduction of disability risk.

The data, to be presented at ECTRIMS, reiterates the fact that Tecfidera holds much promise for patients with RRMS, with reductions in disability progression, relapses, and inflammatory disease outcomes in patients. The data proves that treatment with Tecfidera in newly-diagnosed patients or patients who are early on in their disease course reduces the risk of these disease factors in these patients.