20 Nov FDA Approves VUMERITY™ For Relapsing Forms of Multiple Sclerosis
MedicalResearch.com Interview with:
Aaron Deykin MD
Vice President, Late Stage Clinical Development
MedicalResearch.com: What data support the U.S. Food and Drug Administration’s (FDA) approval of VUMERITY™ (diroximel fumarate)?
Response: The FDA approval of VUMERITY was based on a New Drug Application (NDA) submitted under the 505(b)(2) filing pathway. It included data from pharmacokinetic bridging studies comparing VUMERITY and TECFIDERA® (dimethyl fumarate) to establish bioequivalence, and relied, in part, on the FDA’s findings of safety and efficacy for TECFIDERA.
The NDA submission also included interim exposure and safety findings from EVOLVE-MS-1, an ongoing, Phase 3, single-arm, open-label, two-year safety study evaluating VUMERITY in patients with relapsing-remitting multiple sclerosis (MS). Interim results from EVOLVE-MS-1 at the time of NDA submission included a low overall rate of VUMERITY treatment discontinuation due to adverse events (6.3 percent), and a rate of less than one percent of patients who discontinued VUMERITY treatment due to gastrointestinal (GI) adverse events. Additional exploratory efficacy endpoints in the ongoing EVOLVE-MS-1 study showed changes in clinical and radiological measures compared to baseline.
MedicalResearch.com: How does VUMERITY differ from other medications for MS?
Response: VUMERITY is a novel oral fumarate that offers the well-characterized efficacy of TECFIDERA and has been studied for improved patient-reported GI tolerability. VUMERITY’s distinct chemical structure may contribute to its differentiated tolerability profile.
MedicalResearch.com: What does the clinical development program for VUMERITY include?
Response: The key components of the EVOLVE-MS (Endeavoring to Advance Treatment for Patients Living with Multiple Sclerosis) clinical development program of VUMERITY include the EVOLVE-MS-1 study, an ongoing, Phase 3, open-label, two-year safety study that has enrolled 1,000 RRMS patients, along with pharmacokinetic studies involving VUMERITY and TECFIDERA which demonstrated bioequivalent levels of monomethyl fumarate (MMF) exposure at 462 mg and 240 mg oral dosing levels, respectively.
The EVOLVE-MS clinical development program also includes the EVOLVE-MS-2 study, a Phase 3, five-week, randomized, prospective, double-blind, multi-center study assessing the GI tolerability of VUMERITY and TECFIDERA in 506 patients with relapsing-remitting MS using self-administered GI questionnaires for patient-reported outcomes. The EVOLVE MS-2 study was not part of the NDA submission. Topline results showed a statistically significant benefit with VUMERITY compared to TECFIDERA on the study’s pre-specified primary endpoint; patients treated with VUMERITY self-reported significantly fewer days of key GI symptoms with intensity scores ≥2 on the Individual Gastrointestinal Symptom and Impact Scale (IGISIS), as compared to TECFIDERA (p=0.0003).
MedicalResearch.com: What should readers take away from this FDA approval? What patients are appropriate for VUMERITY?
Response: For newly diagnosed individuals or those who may be considering switching from their current therapy, VUMERITY is a novel oral fumarate that offers people living with relapsing forms of MS a new oral treatment option with the well-characterized efficacy of TECFIDERA and has been studied to evaluate improved patient-reported GI tolerability compared to TECFIDERA.
MedicalResearch.com: What recommendations do you have for future research involving VUMERITY?
Response: Biogen is continuing to assess opportunities that may further expand the body of evidence supporting the efficacy and safety of VUMERITY as well as exploring its mechanism of action. The EVOLVE-MS-1 study (single-arm, prospective, two-year safety study) is ongoing and is expected to complete in the latter half of 2021.
MedicalResearch.com: Is there anything else you would like to add? Any disclosures?
Response: Multiple Scleroisis is a heterogeneous disease, and real-world patient circumstances can vary, reinforcing the benefits of having therapeutic choices to support the diverse range of treatment considerations. The FDA approval of VUMERITY delivers on Biogen’s commitment to pursue new therapies that can provide meaningful impact in the lives of people living with relapsing MS. We are proud of the strong legacy TECFIDERA has achieved over the years and are excited to expand our MS portfolio with the addition of VUMERITY.
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