Vumerity

Zydus Lifesciences received final approval from the U.S. Food and Drug Administration (FDA) to market a generic version of Vumerity (diroximel fumarate) for adults with relapsing forms of multiple sclerosis (MS) and other conditions. The drug will be sold as 231 mg delayed-release capsules, produced at Zydus’s…

Welcome to “MS News Notes,” a column where I comment on multiple sclerosis (MS) news stories that caught my eye last week. Here’s a look at some of what’s been happening: A good report for Vumerity Final results are in from the EVOLVE-MS-1 clinical trial for patients with…

Nearly two years of treatment with Vumerity (diroximel fumarate) significantly reduced relapse rates by more than 80% in people with relapsing-remitting multiple sclerosis (RRMS), according to the final published details of the EVOLVE-MS-1 clinical trial. MRI scans also showed the number of active inflammatory lesions and new…

Up to two years of Vumerity (diroximel fumarate) treatment was generally well-tolerated and led to significant decreases in disease activity in people with relapsing-remitting multiple sclerosis (RRMS), according to a final analysis of data from the open-label EVOLVE-MS-1 Phase 3 clinical trial. Indirect comparisons of Vumerity-treated patients against those…

GoodRx, in collaboration with Biogen, has made the enrollment form for starting a multiple sclerosis (MS) patient on Vumerity (diroximel fumarate) available on its new “Provider Mode” digital platform. By adding the electronic enrollment form, the company hopes doctors will be able to prescribe their patients Vumerity more…

Novartis’ Mayzent (siponimod) and Kesimpta (ofatumumab) are gaining ground among multiple sclerosis (MS) therapies in Canada, according to the latest Spherix Global Insights’ report. “Following an eventful 2021 that included the launch of two new brands — Novartis’ Kesimpta and BMS’ Zeposia — and generic versions of Biogen’s…

Select Brain Stimulation May Ease MS Tremor, But More Study Needed This is encouraging news for the large group of people with MS who are bothered by some sort of tremor. But the procedure to suppress these tremors isn’t simple. We’re talking about deep brain stimulation, where electrodes are…

The National Institute for Health and Care Excellence (NICE) has added oral Vumerity (diroximel fumarate), approved to treat relapsing-remitting multiple sclerosis (RRMS) in the U.K., to the list of medications available through the public health program for England. Because the therapy has been recommended through a fast track appraisal process, Vumerity…

Note: An earlier version of this story stated the Scottish Medicines Consortium approved Vumerity for RRMS patients in that country. The consortium decides to add a medicine to Scotland’s National Health Service; the MHRA approves treatments for England, Scotland, and Wales. The Scottish Medicines Consortium has approved adding the…

The oral medication Vumerity (diroximel fumarate) has been approved by the European Commission to treat adults with relapsing-remitting multiple sclerosis (RRMS). “This approval is a significant step forward in improving treatment adherence for people living with relapsing MS, which can make a meaningful difference on treatment…

A committee of the European Medicines Agency is recommending that Vumerity (diroximel fumarate) be approved as an oral treatment for adults with relapsing-remitting multiple sclerosis (RRMS) in the European Union. The opinion, from the agency’s Committee for Medicinal Products for Human Use (CHMP), will now be sent…

People with relapsing-remitting multiple sclerosis (RRMS) using approved oral disease-modifying therapies generally tolerate the treatments well, with real-world adverse event profiles similar to those seen in clinical trials, an analysis of U.S. data indicates. Results also suggest high adherence to these therapies — meaning patients are usually taking the therapies…

Editor’s note: The Multiple Sclerosis News Today team is providing in-depth coverage of the 2021 Virtual AAN Annual Meeting, April 17–22. Go here to read the latest stories from the conference. Vumerity (diroximel fumarate) continues to be safe and well-tolerated, in addition to reducing measures of disease activity in people…

Vumerity (diroximel fumarate) is easier on the gastrointestinal tract than Tecfidera (dimethyl fumarate), and this translates into better quality of life for patients with relapsing-remitting multiple sclerosis (RRMS), a new analysis of EVOLVE-MS-2 trial data has found. The study, “Improved gastrointestinal profile with diroximel fumarate is…

Tecfidera (dimethyl fumarate), Gilenya (fingolimod), and Ocrevus (ocrelizumab) are losing ground to more recent therapies among U.S. multiple sclerosis (MS) patients switching treatment, according to the latest Spherix Global Insights’ report. The launch of MS generics, bioequivalents, and new brands in the U.S. market over the past year has increased…

Among oral sphingosine-1-phosphate (S1P) receptor modulators for multiple sclerosis (MS), Novartis’s Gilenya (fingolimod) remains physicians’ favorite in the U.S., but prescriptions of recently-launched Bristol Myers Squibb’s Zeposia (ozanimod) are beginning to rise, according to a survey conducted by Spherix Global Insights. Also, COVID-19 not…

Biogen has released new data on several of its therapies for multiple sclerosis (MS), including Vumerity (diroximel fumarate), Tecfidera (dimethyl fumarate), and Tysabri (natalizumab). The data — six presentations — originally were to be presented at the 2020 annual conference of the American…

The U.S. Food and Drug Administration (FDA) has granted orphan drug status to combinations of VTS-Aspirin plus fumarate therapy using Vumerity (diroximel fumarate) or Bafiertam (monomethyl fumarate) for easing flush in patients with relapsing-remitting multiple sclerosis (RRMS). In the U.S., orphan drug designation is given to…

Vumerity (diroximel fumarate) carries fewer and less severe gastrointestinal side effects compared to Tecfidera (dimethyl fumarate), new data from a Phase 3 trial directly comparing the GI tolerability of these two relapsing-remitting multiple sclerosis (RRMS) treatments show. These results were presented at the 27th Annual Meeting of the European Charcot Foundation,…

The National Multiple Sclerosis Society has criticized Biogen for the $88,000 yearly list price it placed on Vumerity (diroximel fumarate), the newly approved oral disease-modifying treatment (DMT) for relapsing multiple sclerosis. That criticism extends to repeated price increases with Tecfidera (dimethyl fumarate), Biogen’s similar oral DMT for…

New 10-year data from the Phase 3 ENDORSE trial confirms the long-term benefits of Biogen’s Tecfidera for patients with relapsing-remitting multiple sclerosis (RRMS), the most common form of this disease. Real-world data from another study also showed Tecfidera to be superior to several other disease-modifying therapies for relapsing MS,…

Fewer and less severe gastrointestinal (GI) side effects were evident in relapsing-remitting multiple sclerosis (RRMS) patients taking the investigational oral treatment Vumerity (diroximel fumarate) twice a day compared to those using Tecfidera (dimethyl fumarate), topline data from the EVOLVE-MS-2 trial show. Vumerity is a fumarate compound being developed…

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…

At the 2019 annual meeting of the American Academy of Neurology (AAN), Multiple Sclerosis News Today sat down with Bernd Kieseier, MD, global head of multiple sclerosis at Biogen, to discuss the company’s portfolio, latest data, and therapeutic development plans in the field of multiple sclerosis (MS). Kieseier said…