Vumerity (diroximel fumarate), taken as a 462 milligram (mg) tablet twice daily, significantly decreases disease activity in patients with relapsing-remitting multiple sclerosis (RRMS), and leads to low rates of gastrointestinal side effects, new interim data of Phase 3 trial EVOLVE-MS-1 show.
The findings were presented at the 2019 Consortium of Multiple Sclerosis Centers (CMSC), held May 28–June 1, in two posters titled “Tolerability of Diroximel Fumarate in Patients With Relapsing-Remitting MS: Analysis of Gastrointestinal and Flushing Events in the Phase 3 EVOLVE-MS-1 Study,” and “Efficacy of Diroximel Fumarate in Relapsing-Remitting MS Patients Who Are Newly Diagnosed or Previously Treated With Interferons or Glatiramer Acetate”.
Vumerity, in development by Alkermes and Biogen, is an investigational oral therapy for RRMS, currently under review by the U.S. Food and Drug Administration. A decision is expected in the fourth quarter of this year.
The effectiveness and safety of Vumerity in RRMS patients is being tested in the ongoing, open-label, two-year Phase 3 clinical trial EVOLVE-MS-1 (NCT02634307). The trial is being carried out in multiple European countries and the United States, and is enrolling approximately 1,000 patients by invitation.
Enrolled RRMS patients are categorized into subgroups, including those who were newly diagnosed and are treatment naïve, and those who had been previously treated with interferon or with Teva’s Copaxone (glatiramer acetate).
Interim results from RRMS patients treated with Vumerity for approximately one year were presented at the CMSC meeting.
Post-hoc sub-group analysis of the trial data compared adjusted annualized relapse rates and the number of gadolinium-enhancing lesions (MS lesions with active inflammation) following treatment to the patients’ baseline levels, (i.e., before the trial started).
The analysis included 82 newly diagnosed patients and 361 patients who had been treated previously.
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