Enrollment is now complete in the twin Phase 3 clinical trials testing Immunic Therapeutics‘ oral small molecule vidofludimus calcium in adults with relapsing forms of multiple sclerosis (MS). ENSURE-1 (NCT05134441) has enrolled 1,121 patients and ENSURE-2 (NCT05201638) has enrolled 1,100 patients at more than 100…

The U.S. Food and Drug Administration (FDA) has approved a new generic form of glatiramer acetate injection, a treatment for relapsing forms of multiple sclerosis (MS) that was originally approved under the brand name Copaxone. The generic was developed by Zydus Lifesciences in collaboration with Chemi S.p.A.,…

A single 600 mg dose of Briumvi (ublituximab-xiiy) — instead of the approved 150 mg initial dose plus a 450 mg dose two weeks later — was well tolerated by adults with relapsing forms of multiple sclerosis (MS). That’s according to new data from the ENHANCE Phase…

Evidence of neurological damage over time — known as dissemination in time, or DIT — may not be necessary to reach a diagnosis of multiple sclerosis (MS) for all patients, according to a report by U.K. researchers. Traditionally, an MS diagnosis would typically require both DIT and DIS,…

Using Ocrevus (ocrelizumab) as a first-line treatment for early-stage relapsing forms of multiple sclerosis (MS) is significantly better at delaying disease progression than starting with a less effective drug and switching to Ocrevus later. That’s according to nine years of data from the OPERA I (NCT01247324) and…

Cabaletta Bio is getting set to launch a clinical trial testing its cell therapy resecabtagene autoleucel (rese-cel) in people with relapsing and progressive forms of multiple sclerosis (MS). The company sought permission last year from the U.S. Food and Drug Administration (FDA) to start the study. Once such…

Sanofi has ended a Phase 2 clinical trial into oditrasertib, an investigational RIPK1 inhibitor therapy, in people with relapsing and progressive multiple sclerosis (MS) after it failed to meet its goals. The study, which had started dosing early last year, failed to show that oditrasertib significantly lowered…

A year of treatment with the experimental BTK inhibitor fenebrutinib was safe and nearly entirely suppressed signs of disease activity, including relapses, disability progression, and brain lesions, in people with relapsing forms of multiple sclerosis (MS), according to new data from the open-label extension part of a Phase…

For people recently diagnosed with multiple sclerosis (MS), first-line treatment with Kesimpta (ofatumumab) was associated with a lower risk of disability progression over starting it after about 2.5 years of using Aubagio (teriflunomide). That’s according to six years of data spanning the ASCLEPIOS I (NCT02792218) and…

Vanda Pharmaceuticals has acquired the U.S. and Canadian rights to Ponvory (ponesimod), an oral therapy approved for relapsing types of MS, in a new deal with Actelion Pharmaceuticals. Under the terms of the agreement, Vanda paid $100 million to Actelion (now part of Janssen), the therapy’s original developer. While…

Immunic Therapeutics has been notified of the intent to grant a U.S. patent covering the use vidofludimus calcium (IMU-838) in treating relapsing forms of multiple sclerosis (MS) at a daily dose of about 10 to 45 mg. That range covers the two IMU-838 doses shown to be…

People with relapsing multiple sclerosis (MS) who experienced disease activity while on oral therapies had less disease activity after switching to Kesimpta (ofatumumab), according to an analysis of data from the Phase 3 ARTIOS clinical trial. The patients previously were on Gilenya (fingolimod), or fumarate-based therapies such…

Long-term treatment with Ocrevus (ocrelizumab) doesn’t change the diversity of T-cells — those needed to mount effective immune responses against foreign pathogens — in people with relapsing multiple sclerosis (MS) patients, a small study shows. Consistent with its mechanism of B-cell depletion, however, Ocrevus did reduce the molecular…

Genentech‘s investigational BTK inhibitor fenebrutinib significantly reduced the number of new brain lesions and showed no new safety concerns in people with relapsing forms of multiple sclerosis (MS). That’s according to new data from the company’s Phase 2 FENopta clinical trial (NCT05119569), which is evaluating fenebrutinib’s…

Nearly half of the people with relapsing forms of multiple sclerosis (MS) treated early with Ocrevus (ocrelizumab) in Phase 3 clinical trials showed no evidence of disease activity after up to nine years on the therapy, data show. In contrast, about one-quarter of enrolled patients who started on…

The benefits of Mavenclad (cladribine) were sustained for up to 15 years after its last treatment course in people with relapsing multiple sclerosis (MS), according to real-world data from the CLASSIC-MS study. More than half of those who received the oral therapy in the clinical trials that supported…

Most neurologists in the U.S. are aware of the recent approval of Briumvi (ublituximab-xiiy) for the treatment of relapsing forms of multiple sclerosis (MS) and about half anticipate testing the therapy in the next six months, according to an analysis by market research company Spherix Global Insights. The therapy, developed…

Changes in mitochondria — cells’ energy production centers — are evident in early disease stages in a mouse model of progressive multiple sclerosis (MS), but were not found in a model of relapsing-remitting MS (RRMS), according to researchers. These changes, seen before symptoms of the disease started, were…

The U.S. Food and Drug Administration has approved TG Therapeutics‘ B-cell-depleting therapy ublituximab under the brand name Briumvi for the treatment of adults with relapsing forms of multiple sclerosis (MS), the company announced. The approval covers clinically isolated syndrome, relapsing-remitting MS (RRMS), and active secondary progressive…

The levels of two cerebrospinal fluid (CSF) biomarkers, CHI3L1 and CXCL13, were significantly elevated in people with relapsing and progressive multiple sclerosis (MS) relative to control groups without this disease, and are most likely to predict how relapsing MS will progress, a study reported. Higher levels of these biomarkers were also…

People with relapsing multiple sclerosis who have disability progression, but no clinical relapses, show significantly faster brain shrinkage, or atrophy, than those with a stable disease, a study shows. There were no significant differences in the brain atrophy rate between patients with progression independent of relapse activity (PIRA) and…

Long-term treatment with evobrutinib safely and effectively reduces the rate of relapses in adults with relapsing forms of multiple sclerosis (MS), according to 2.5 years of data from a Phase 2 extension study. These findings — supporting evobrutinib’s therapeutic potential in relapsing MS — were shared in an…

Higher doses of temelimab were generally safe and resulted in beneficial trends on key neurodegeneration markers in adults with relapsing forms of multiple sclerosis (MS) who already were on rituximab treatment, according to top-line data from the ProTEct-MS Phase 2 clinical trial. While the study’s small size…

A measure of the nose’s sensitivity to smell could be used to detect whether treatments for relapsing multiple sclerosis (MS) are working or not, a new study indicates. The scientists noted that their results need to be validated through further study, but said the findings suggest that a smell…

The experimental medication ublituximab significantly reduces the number of new brain lesions with severe nerve cell degeneration in people with relapsing multiple sclerosis (MS) as compared with Aubagio (teriflunomide), according to new data from the Phase 3 ULTIMATE clinical trials. The findings showed that ublituximab induces a rapid…

A Phase 2 clinical trial into the safety and tolerability of higher-dose temelimab as a potential therapy for relapsing forms of multiple sclerosis (MS) is now complete, and top-line data is expected by late March, its developer, GeNeuro, announced. The ProTEct-MS Phase 2 trial (NCT04480307), conducted at the Karolinska…

The U.S. Food and Drug Administration (FDA) has agreed to review TG Therapeutics’ application seeking the approval of ublituximab as a treatment for people with relapsing forms of multiple sclerosis. An FDA’s decision is expected on or before Sept. 28. The agency is not currently planning to hold an…

Patients with relapsing multiple sclerosis (MS) treated with subcutaneous cladribine saw limited disease progression over a follow-up period of up to 20 years, especially with increased cumulative dosing, according to a recent study. Subcutaneous (SC) cladribine is administered as an under-the-skin injection. It is a formulation different from…

It’s been a decade since the opening of the UK MS Register, which sought to gain a better understanding of how multiple sclerosis (MS) affects patients’ everyday lives, with a goal, according to its website, toward fueling campaigns for “fair, relevant policy and improved health care.” Now, the…

TG Therapeutics  has applied to the U.S. Food and Drug Administration (FDA) for approval of ublituximab, the company’s investigational anti-CD20 monoclonal antibody therapy for relapsing forms of multiple sclerosis (RMS). Its application was based on data from the ULTIMATE 1 (NCT03277261) and ULTIMATE 2 (NCT03277248) Phase…