relapsing MS

Researchers analyze switching to Kesimpta from oral therapies

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…

Ublituximab, Now Briumvi, Approved in US for Relapsing Forms of MS

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…

2 Biomarkers Seen as Best at Predicting Course of Relapsing MS

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…

Ublituximab as Relapsing MS Therapy Under FDA Review

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…

Ublituximab, Potential Relapsing MS Therapy, Up for FDA Approval

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…

Ocrevus Reduces MS Relapse Risk, But Linked to More Hospitalizations

Ocrevus (ocrelizumab) reduces relapse risk and slows disability progression in multiple sclerosis (MS) but also is associated with higher hospitalization rates in older people with relapsing forms of the disease, a new observational study reports. Hospitalizations — which occurred mainly due to urinary tract infections — were more frequent…

One-third of Patients in the UK Hid MS Status, Poll Finds

An MS Society survey found that about one-third of people with multiple sclerosis (MS) in the U.K. have kept their condition hidden from their partner, family members, employer, or work colleagues. To help mark MS Awareness Week, observed in the U.K. April 19–25, the nonprofit organization released…

Kesimpta Approved in UK as At-home Relapsing MS Therapy

Kesimpta (ofatumumab) has been approved in the U.K. as the first self-administered, at-home, B-cell-targeting therapy for people with relapsing forms of multiple sclerosis (MS) and active disease. More specifically, the approval includes patients with either clinically isolated syndrome, relapsing-remitting MS (RRMS), or active secondary progressive MS (SPMS), who have…

Tecfidera Approved in China to Treat Relapsing MS

Tecfidera (dimethyl fumarate) was given the green light by health regulators in China to treat people with relapsing multiple sclerosis (MS) — clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS. The National Medical Products Administration’s (NMPA) decision came through a priority review of clinical trial data for Tecfidera,…

Kesimpta Approved in EU as At-home Injectable Therapy for Relapsing MS

The European Commission has approved Novartis’ Kesimpta (ofatumumab) as the first self-administered, at-home B-cell-targeting therapy for adults with relapsing forms of multiple sclerosis (MS) and active disease. Active disease in these forms, which include clinically isolated syndrome, relapsing-remitting MS (RRMS), and active secondary progressive MS (SPMS),…

Safety Board Says Phase 2 Temelimab Trial Should Move Forward

A Phase 2a clinical trial evaluating GeNeuro‘s investigational antibody temelimab as a treatment for relapsing multiple sclerosis (MS) should continue as planned, without modifications. That’s the recommendation of a Drug Safety Monitoring Board, an independent committee of clinical research experts, which was evaluating the trial of the…