April 18, 2022 Columns by Ed Tobias MS News That Caught My Eye Last Week: Deep Brain Stimulation, IMCY-0141, Foralumab, Vumerity 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…
April 14, 2022 News by Marisa Wexler, MS Vumerity Added to NHS of England for People With Active RRMS The National Institute for Health and Care Excellence (NICE) has added oralĀ Vumerity (diroximel fumarate), approved to treatĀ relapsing-remitting multiple sclerosisĀ (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…
February 9, 2022 News by Marisa Wexler, MS Vumerity Added to NHS of Scotland for People With Active RMMS 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 Scotlandās National Health Service; the MHRA approves treatments for England, Scotland, and Wales. The Scottish Medicines Consortium has approved adding the…
November 17, 2021 News by Marisa Wexler, MS Vumerity Approved for RRMS in European Union 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…
September 20, 2021 News by Marisa Wexler, MS Vumerity Recommended for EU Approval as RRMS 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 sclerosisĀ (RRMS) in the European Union. The opinion, from the agency’s Committee for Medicinal Products for Human Use (CHMP), will now be sent…
May 5, 2021 News by Marisa Wexler, MS Safety of Oral DMTs for RRMS in Real-world Use Seen to Match Trial Findings People with relapsing-remitting multiple sclerosis (RRMS) using approved oral disease-modifyingĀ therapiesĀ 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 ā meaning patients are usually taking the therapies…
April 28, 2021 News by Forest Ray PhD #AANAM ā Vumerity Showing Tolerability, Efficacy in Ongoing EVOLVE-MS-1 Trial Editorās note: TheĀ Multiple Sclerosis News TodayĀ team is providing in-depth coverage of the 2021 Virtual AAN Annual Meeting, April 17ā22. GoĀ hereĀ 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…
April 13, 2021 News by Margarida Maia, PhD Vumerity Linked to Better Quality of Life Than Tecfidera in RRMS Trial 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, āImproved gastrointestinal profile with diroximel fumarate is…
May 20, 2020 News by Marisa Wexler, MS Biogen Presents Update on its MS Therapeutic Portfolio 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 ā six presentations ā originally were to be presented at the 2020 annual conference of the American…
November 14, 2019 News by Grace Frank Vumerity’s $88,000 List Price Not What ‘We Had Hoped,’ National MS Society Says The National Multiple Sclerosis Society has criticized BiogenĀ for the $88,000 yearly list price it placed onĀ VumerityĀ (diroximel fumarate), the newly approved oral disease-modifying treatment (DMT) for relapsing multiple sclerosis. That criticism extends to repeated price increases withĀ TecfideraĀ (dimethyl fumarate), Biogen’s similar oral DMT for…
September 11, 2019 News by Patricia Inacio, PhD #ECTRIMS2019 – 10-year Data Confirm Long-term Benefits of Biogen’s Tecfidera for RRMS New 10-year data from the Phase 3 ENDORSE trial confirms the long-term benefits of Biogenās TecfideraĀ for patients with relapsing-remitting multiple sclerosisĀ (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,…
August 1, 2019 News by Ana Pena PhD Oral Vumerity Easier on Gastrointestinal Tract Than Tecfidera, Phase 3 Trial Finds Fewer and less severe gastrointestinal (GI) side effects were evident inĀ relapsing-remitting multiple sclerosis (RRMS) patients taking the investigational oral treatment Vumerity (diroximel fumarate) twice a day compared to those usingĀ Tecfidera (dimethyl fumarate), topline data from the EVOLVE-MS-2 trial show. Vumerity is aĀ fumarate compound being developed…
June 4, 2019 News by Patricia Inacio, PhD Vumerity’s Safety, Effectiveness Bolstered by New Data from EVOLVE-MS-1 Trial Vumerity (diroximel fumarate), taken as a 462 milligram (mg) tablet twice daily, significantly decreases disease activity in patients withĀ relapsing-remitting multiple sclerosisĀ (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…
May 15, 2019 News by Marisa Wexler, MS #AANAM – Biogen Offers Update on Development Plans for MS Therapies At the 2019 annual meeting of the American Academy of Neurology (AAN),Ā Multiple Sclerosis News TodayĀ 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…
March 4, 2019 Columns by Ed Tobias MS News that Caught My Eye Last Week: New DMT, Stem Cell Trial, Pediatric MS Treatment Study FDA Will Review New Drug Application of Diroximel Fumarate for Relapsing Forms of MS The good news: Another disease-modifying therapy (DMT) has taken a step toward approval in the U.S. The discouraging news: It’s another DMT designed to treat relapsing forms of multiple sclerosis. More than a…
February 27, 2019 News by Alice MelĆ£o, MSc FDA Will Review New Drug Application of Diroximel Fumarate for Relapsing Forms of MS The U.S. Food and Drug Administration (FDA) has agreed to review Alkermesā request to approve diroximel fumarate (BIIB098) as a treatment for relapsing forms of multiple sclerosis (MS), the company announced. A final decision by the FDA is expected in the fourth quarter of 2019. If approved, diroximel…
December 18, 2018 News by Alice MelĆ£o, MSc FDA Asked to Approve Diroximel Fumarate as Oral Treatment for Relapsing MS AlkermesĀ filed a request for the approval of diroximel fumarate (BIIB098) to treatĀ relapsing forms of multiple sclerosis (MS) with the U.S. Food and Drug Administration (FDA). If approved, diroximel fumarate will be marketed by BiogenĀ in the U.S., likely under the brand name Vumerity. Alkermes and Biogen are working…