Ny data för TECFIDERA® presenterades på ECTRIMS

Ny data för TECFIDERA® presenterades på ECTRIMS

Ny data som presenteras på ECTRIMS bekräftar långsiktig behandlingsnytta av TECFIDERA® (dimetyl fumarat över en 10 års period

Biogen Inc. (Nasdaq: BIIB) announced new data to support the consistent, long-term benefits of treatment with dimethyl fumarate over 10 years, as well as additional diroximel fumarate data that further characterize the tolerability profile of this investigational oral fumarate for relapsing multiple sclerosis (MS). These findings are being presented at the 35th Congress of the European Committee for Treatment and Research in MS (ECTRIMS) and 24thAnnual Conference of Rehabilitation in MS in Stockholm (September 11-13).

“Biogen’s new data underscore the role of dimethyl fumarate as a option for relapsing MS, with many patients in the study experiencing no relapses or progression in their disability over a 10-year period,” said Alfred Sandrock, Jr., M.D., Ph.D., executive vice president and chief medical officer at Biogen. “We are proud of the legacy dimethyl fumarate has achieved over the years and are excited to continue building our franchise of fumarate products with the potential addition of diroximel fumarate. Diroximel fumarate offers a differentiated gastrointestinal tolerability profile and, if approved, will be a potential choice for physicians and patients with relapsing MS to consider.”

The dimethyl fumarate 10-Year Data

New results from the ongoing Phase 3 ENDORSE extension study reinforce the long-term effectiveness and safety of continuous DIMETHYL FUMARATE treatment over a decade. The analysis, included participants (N= 192) with at least 10 years of follow up. Results show that approximately half (51 percent) of patients remained relapse-free over the study period. In addition, 64 percent of patients had no confirmed disability progression over the study period, and patients generally maintained the ability to walk without significant disability (79 percent). The safety profile of DIMETHYL FUMARATE was consistent over 10 years, with no increased occurrence of serious infections.

Separately, a meta-analysis of real-world evidence to compare the effectiveness of DIMETHYL FUMARATE versus other disease-modifying therapies for relapsing MS is also being presented. The meta-analysis analyzed data from 18 databases of large real-world studies and found that DIMETHYL FUMARATE was significantly more effective than interferon beta, glatiramer acetate and teriflunomide in reducing annualized relapse rate and delaying time to first relapse. DIMETHYL FUMARATE demonstrated comparable effectiveness to fingolimod and was less effective than natalizumab and alemtuzumab. These results are consistent with previously reported comparative effectiveness data.

Data Support Diroximel Fumarate as a Potential New Option for Relapsing MS

Updated interim data from the Phase 3 EVOLVE-MS-1 study support the potential of Biogen and Alkermes’ investigational treatment, diroximel fumarate, as a novel oral fumarate. EVOLVE-MS-1 is an ongoing, single-arm, open-label, two-year study evaluating the safety and exploring the efficacy of diroximel fumarate in patients with relapsing-remitting MS and has enrolled approximately 1,000 patients. The interim results, which included data from 888 patients treated with diroximel fumarate for a median of approximately 18 months, corroborate previous data indicating diroximel fumarate is generally well-tolerated in people with relapsing MS.

In the study, most adverse events were mild to moderate in nature. 16.3 percent of treatment discontinuation were reported overall, with less than 1 percent of patients discontinuing diroximel fumarate treatment due to gastrointestinal (GI) side effects. These data are further supportive of recently reported topline results from the elective Phase 3 EVOLVE-MS-2 study, in which diroximel fumarate demonstrated statistically superior GI tolerability compared to DIMETHYL FUMARATE based on patient-reported outcomes.

Exploratory efficacy results from EVOLVE-MS-1 suggest diroximel fumarate significantly reduced annualized relapse rate by 79.4 percent and the mean number of gadolinium-enhancing lesions by 64.3 percent compared to baseline over 18 months, with similar results observed in newly diagnosed patients.

Featured data presentation details:

  • Overall Safety and Efficacy Through 10 Years of Treatment with Delayed-release Dimethyl Fumarate in Patients with Relapsing-Remitting Multiple Sclerosis (P1397; Poster Session 3, Friday, September 13, 12:15-2:15 pm CET)
  • Comparative Effectiveness of Delayed-release Dimethyl Fumarate vs. Other Disease-modifying Therapies in Patients with Multiple Sclerosis: A Network Meta-analysis of Real-world Evidence (P1394; Poster Session 3, Friday, September 13, 12:15-2:15 pm CET)
  • Diroximel Fumarate (DRF) in Patients with Relapsing-Remitting Multiple Sclerosis: Interim Safety and Efficacy Results from the Phase 3 EVOLVE-MS-1 Study (ePoster; available for duration of congress)