Drug Evaluation

Department of Neurology, Hospital South West Jutland, University Hospital of Southern Denmark, Esbjerg, Denmark

‡All authors contributed equally

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Tobias Sejbaek‡

*Author for correspondence: Tel.: +457 9183 105;

E-mail Address: tobias.sejbaek@rsyd.dk

https://orcid.org/0000-0002-7682-2188

Department of Neurology, Hospital South West Jutland, University Hospital of Southern Denmark, Esbjerg, Denmark

BRIDGE, Brain Research - Inter-Disciplinary Guided Excellence, Department of Regional Health Research, University of Southern Denmark, Esbjerg, Denmark

MS Alliance of Southern Denmark, Esbjerg, Denmark

‡All authors contributed equally

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Published Online:20 Jul 2020https://doi.org/10.2217/nmt-2020-0025

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Abstract

Diroximel fumarate (DRF) is a new emerging therapy for patients with multiple sclerosis. The levels of its active metabolite, monomethyl fumarate, are bioequivalent to the levels generated from dimethyl fumarate (DMF) treatment. The efficacy and safety profiles of DRF are expected to be similar to the well-established profiles of DMF. The metabolism of DRF leads to lower concentration of methanol in the small intestine than with DMF and thus reduced severity and frequency of gastrointestinal adverse events. DRF seems a promising alternative to DMF and other first-line therapies for multiple sclerosis. The current review is based on the two existing Phase III trials of DRF: the interim analysis of the EVOLVE-MS-1 trial and the completed EVOLVE-MS-2 trial.

Keywords:

Papers of special note have been highlighted as: • of interest; •• of considerable interest

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Vol. 10, No. 5

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History

Received 18 May 2020

Accepted 22 June 2020

Published online 20 July 2020

Published in print October 2020

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Keywords

Acknowledgments

The authors thank C Gudex, Department of Clinical Research/OPEN, University of Southern Denmark, for proofreading the manuscript.

Financial & competing interests disclosure

E Jonasson has nothing to disclose. T Sejbaek has received travel grants from Biogen, Merck, Novartis and Roche, has received research grants from Biogen and has served on advisory boards for Biogen and Novartis. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

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Diroximel fumarate in the treatment of multiple sclerosis

Abstract

References