Biogen To Present Data On The Effectiveness of TECFIDERA In Newly-Diagnosed MS Patients During The ANN Annual Meeting

Biogen has recently announced novel results to support the effectiveness of TECFIDERA (dimethyl fumarate) in the treatment of patients with relapsing-remitting multiple sclerosis (RRMS).

The results revealed that TECFIDERA significantly reduced disability progression and relapses in RRMS patients who received their diagnosis for the first time and had a highly active form of the disease. TECFIDERA proved effective for periods longer than five years in those patients who had been treated before with interferon (interferon beta-1a/b [IFN]) or with glatiramer acetate (GA).

This important data will be presented during the 67^th Annual Meeting of the American Academy of Neurology (AAN), Washington, DC.

“Taken together, these studies reinforce that TECFIDERA delivers robust efficacy when used as a first-line therapy, as well as when it is used after a patient has discontinued interferon or glatiramer acetate treatment,” said J. Theodore Phillips, M.D., Ph.D., research investigator at the Baylor Institute for Immunology Research and clinical professor of Neurology at the University of Texas Southwestern Medical Center in a recent press release. “In addition, strong efficacy was observed with TECFIDERA treatment in various patient populations including those with highly active MS.”

The efficacy of TECFIDERA in recent-diagnosed RRMS patients with highly active disease activity was observed in a post-hoc data analysis of two years of integrated data from the DEFINE and CONFIRMS Phase 3 clinical trials.

RRMS patients who were included in this analysis had their diagnosis one year before enrollment in the studies, and were considered either treatment-naïve or had been treated before with corticosteroids alone. All subjects met the criteria for highly active MS, meaning they had two or more relapses within one year before enrollment in the studies.

At two years, the results revealed that TECFIDERA (n=84) significantly reduced the annual relapse rate (ARR), with a 56% reduction when compared to the placebo group (n=77). The proportion of patients who relapsed (56% reduction) and time to sustained 12-week progression of disability (78% reduction), were also reduced in comparison to the control group.

“TECFIDERA continues to demonstrate consistently strong efficacy and favorable safety results that we believe support its position as the new oral standard of care,” said Gilmore O’Neill, vice president, Multiple Sclerosis Research and Development at Biogen in the press release. “More than 135,000 patients have been treated with TECFIDERA worldwide since it was introduced to the market two years ago.”

According to an integrated post-hoc analysis in a subgroup of RRMS patients who were followed for a minimum of five years from the Phase 3 CONFIRM, DEFINE, and ENDORSE clinical trials, TECFIDERA is effective in treating RRMS patients who were treated before with IFN or GA.

The results revealed that during the whole study period, ARR remained low in those RRMS patients who received constant treatment with TECFIDERA, when compared to patients who received two years of placebo in DEFINE/CONFIRM studies.

In those patients who moved from placebo in the DEFINE and CONFIRM trials to TECFIDERA in the ENDORSE trial, the results revealed ARR improvements even if patients were treatment-naïve or had been treated before with IFN or GA.

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Specifically the results showed that in treatment-naïve patients:

• Those who received TECFIDERA (n=267) for five years had an ARR of 0.123;
• Those who switched to TECFIDERA in year three (n=133) had an ARR of 0.207;

Patients who received treatment with one or more prior IFN/GA therapy:

• Those who received TECFIDERA (n=124) for five years had an ARR of 0.195;
• Those who switched to TECFIDERA in year three (n=68) had an ARR of 0.253.

In terms of safety the results from the ENDORSE trial were coherent with the ones found in the DEFINE and CONFIRM trials, within a minimum observation period of five years, with no increase in the risk of infections.

These results will be presented during a poster session on the 23^rd of April at 2:00 p.m., titled:

• “Long-Term Efficacy of Delayed-Release Dimethyl Fumarate for Relapsing-Remitting Multiple Sclerosis According to Prior Therapy: Integrated Analysis of the DEFINE, CONFIRM, and ENDORSE Studies (poster P7.229)”
• “Clinical Efficacy of Delayed-Release Dimethyl Fumarate in Newly Diagnosed Relapsing-Remitting Multiple Sclerosis Patients with Highly Active Disease: An Integrated Analysis of the Phase 3 DEFINE and CONFIRM Studies (poster P7.228)”

ENDORSE is an ongoing global, dose-blind, Phase 3 extension study that intends to determine the long-term safety and efficacy of TECFIDERA (at a dosing of 240 mg, BID or TID), in 1,738 patients with RRMS who completed the DEFINE or CONFIRM studies.

DEFINE (Determination of the Efficacy and safety of oral Fumarate IN relapsing-rEmitting MS) was a multinational and multi center two-year, randomized, placebo-controlled, double-blind, dose-comparison Phase 3 clinical trial that enrolled more than 1,200 patients with RRMS at 198 sites in 28 countries, to examine the efficacy of TECFIDERA (at a dosing of 240 mg, BID or TID) compared to placebo.

CONFIRM (COmparator and aN oral Fumarate In Relapsing-remitting MS) was a multinational and multicentre, two-year, randomized, placebo-controlled, double-blind, dose-comparison Phase 3 trial that enrolled approximately 1,400 patients with RRMS in 28 countries across 200 research sites. The study examined TECFIDERA (at a dosing of 240 mg, BID or TID) in comparison to placebo and involved a reference comparator study arm of placebo versus glatiramer acetate (GA; at a dose of 20 mg subcutaneous daily injection).

Currently, TECFIDERA is approved in the European Union, Canada, Australia, the United States, and Switzerland. At the moment, more than 135,000 patients have received treatment with TECFIDERA through a clinical trial program and commercial launches which started in the United States in March 2013.