Diroximelfumarate (relapsing remitting multiple sclerosis) - Benefit assessment according to '35a Social Code Book V 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Diroximelfumarat (multiple Sklerose) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 30 March 2022). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. Extract IQWiG Reports – Commission No. A21-172 Diroximelfumarate (multiple sclerosis) – Benefit assessment according to §35a Social Code Book V1 Extract of dossier assessment A21-172 Version 1.0 Diroximelfumarate (multiple sclerosis) 30 March 2022 Institute for Quality
Diroximelfumarate (Vumerity) - treatment of adult patients with relapsing remitting multiple sclerosis Published 07 February 2022 1 Product update SMC2444 diroximelfumarate 231mg gastro-resistant hard capsules (Vumerity®) Biogen 14 January 2022 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and, following review by the SMC executive, advises NHS Boards and Area Drug and Therapeutics Committees (ADTCs) on its use in NHSScotland. The advice is summarised as follows: ADVICE: following an abbreviated submission diroximelfumarate (Vumerity®) is accepted for use within NHSScotland. Indication under review: treatment of adult patients with relapsing remitting multiple sclerosis. Diroximelfumarate provides an additional treatment choice
Diroximelfumarate acts through Nrf2 to attenuate methylglyoxal-induced nociception in mice and decrease ISR activation in DRG neurons. Diabetic neuropathic pain is associated with elevated plasma levels of methylglyoxal (MGO). MGO is a metabolite of glycolysis that causes pain hypersensitivity in mice by stimulating the phosphorylation of eukaryotic initiation factor 2α (p-eIF2α ) and subsequently activating the integrated stress response (ISR). We first established that Zucker Diabetic Fatty (ZDF) rats have enhanced MGO signaling, engage the ISR, and develop pain hypersensitivity. Since nuclear factor erythroid 2-related factor 2 (Nrf2) regulates the expression of antioxidant proteins that neutralize MGO, we hypothesized that fumarates, like diroximelfumarate (DRF), will stimulate Nrf2
DiroximelFumarate in Patients with Relapsing-Remitting Multiple Sclerosis: NEDA-3 After Re-Baselining in the Phase 3 EVOLVE-MS-1 Study. Diroximelfumarate (DRF) and dimethyl fumarate (DMF) are orally administered fumarate disease-modifying therapies (DMTs) for multiple sclerosis (MS). The safety, tolerability, and exploratory efficacy of DRF were evaluated in the phase 3 EVOLVE-MS-1 study
Comparative efficacy of diroximelfumarate, ozanimod and interferon beta-1a for relapsing multiple sclerosis using matching-adjusted indirect comparisons. Diroximelfumarate (DRF), ozanimod (OZA) and interferon beta-1a (IFN) are disease-modifying therapies approved for the treatment of relapsing multiple sclerosis. No randomized trials have compared DRF versus OZA and IFN. We compared DRF versus
Matching-Adjusted Indirect Comparisons of DiroximelFumarate, Ponesimod, and Teriflunomide for Relapsing Multiple Sclerosis. Diroximelfumarate (DRF), ponesimod (PON), and teriflunomide (TERI) are oral disease-modifying therapies approved for the treatment of relapsing multiple sclerosis. No randomized trials have compared DRF versus PON or TERI. The objectives of this analysis were to compare
Comparative pharmacokinetics and bioavailability of monomethyl fumarate following a single oral dose of Bafiertam® (monomethyl fumarate) versus Vumerity® (diroximelfumarate). Bafiertam® (monomethyl fumarate [MMF]) and Vumerity® (diroximelfumarate [DRF]) are two FDA approved drug products for the treatment of relapsing forms of multiple sclerosis (MS) to include clinically isolated syndrome
Efficacy and Safety Outcomes with DiroximelFumarate After Switching from Prior Therapies or Continuing on DRF: Results from the Phase 3 EVOLVE-MS-1 Study. Diroximelfumarate (DRF) is an oral fumarate for relapsing multiple sclerosis (MS) with the same active metabolite as dimethyl fumarate (DMF). DRF has a safety/efficacy profile similar to DMF but with improved gastrointestinal (GI
Improved gastrointestinal profile with diroximelfumarate is associated with a positive impact on quality of life compared with dimethyl fumarate: results from the randomized, double-blind, phase III EVOLVE-MS-2 study. Diroximelfumarate (DRF) is a novel oral fumarate approved for relapsing forms of multiple sclerosis (MS). DRF demonstrated significantly improved gastrointestinal (GI
DiroximelFumarate An official website of the United States government Here's how you know Log inAccess keysNCBI HomepageMyNCBI HomepageMain ContentMain NavigationBookshelfSearch databaseBooksAll DatabasesAssemblyBiocollectionsBioProjectBioSampleBooksClinVarConserved DomainsdbGaPdbVarGeneGenomeGEO DataSetsGEO ProfilesGTRHomoloGeneIdentical Protein GroupsMedGenMeSHNLM Levels and EffectsSummary of Use during LactationNo information is available on the clinical use of diroximelfumarate during breastfeeding. However, amounts of the active metabolite of diroximelfumarate, monomethyl fumarate, in breastmilk appear to be low and would not be expected to cause any adverse effects in breastfed infants. Based on clinical data in over 20 infants exposed to dimethyl fumarate
DiroximelFumarate Demonstrates an Improved Gastrointestinal Tolerability Profile Compared with Dimethyl Fumarate in Patients with Relapsing-Remitting Multiple Sclerosis: Results from the Randomized, Double-Blind, Phase III EVOLVE-MS-2 Study. Diroximelfumarate (DRF) is a novel oral fumarate approved in the USA for relapsing forms of multiple sclerosis. DRF is converted to monomethyl fumarate
Pregnancy Exposure Registry for Vumerity (DiroximelFumarate) The primary objectives of the study are to estimate the risk of major congenital malformations (MCMs) in infants born to women with multiple sclerosis (MS) who were exposed to diroximelfumarate (DRF) at any time from 2 weeks after the first day of their last menstrual period (LMP) up through the first trimester of pregnancy
A Study to Assess Pregnancy Outcomes in Women Exposed to DiroximelFumarate The primary objective of the study is to estimate the prevalence of major congenital malformations (MCMs) and compare the prevalence between the diroximelfumarate (DRF) and comparator groups. The secondary objectives of the study are to estimate the incidence of spontaneous abortion (SA) and compare the incidence between
A Study of DiroximelFumarate (DRF) in Adult Participants From the Asia-Pacific Region With Relapsing Forms of Multiple Sclerosis (RMS) The primary objectives of this study are to determine the safety and tolerability of DRF administered for up to 24 weeks in adult East Asian participants with RMS (Part 1) and to determine the safety and tolerability of DRF administered for up to 48 weeks
Exploring DiroximelFumarate Real-world Experience in Canada and Israel The primary objective of the study is to characterize the persistence to therapy in participants with relapsing forms of multiple sclerosis (RMS) treated with diroximelfumarate (DRF) in routine clinical practice. The secondary objectives of the study are to assess short-term persistence to treatment; to assess long-term
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of DiroximelFumarate (DRF) in Chinese and Caucasian Adult Healthy Participants The primary objective is to evaluate the primary pharmacokinetic (PK) parameters of DRF active metabolite monomethyl fumarate (MMF) following multiple doses of DRF in Chinese and Caucasian adult healthy participants. The secondary objectives
Study of DiroximelFumarate in the Real-World Setting The primary objective of the study is to characterize the persistence to therapy in participants with relapsing forms of multiple sclerosis (RMS) treated with diroximelfumarate (DRF) in routine clinical practice. The secondary objectives of the study are to assess short-term persistence to treatment; to assess long-term persistence
no evidence of a severe course of disease Dimethyl fumarate or diroximelfumarate or glatiramer acetate or IFN-β1a or IFN-β1b or teriflunomide 2 Adults with RMS who have not yet received disease-modifying therapy and show evidence of a severe course of disease and adults who show an active course of disease despite treatment with a disease-modifying therapy Individualized therapyc, d taking into account Dimethyl fumarate or diroximelfumarate or glatiramer acetate or IFN-β1a or IFN-β1b or teriflunomide Added benefit not proven 2 Adults with RMS who have not yet received disease-modifying therapy and show evidence of a severe course of disease and adults who show an active course of disease despite treatment with a disease-modifying therapy Individualized therapyc, d taking into account the disease