ublituximab

TG Therapeutics’ Briumvi (ublituximab-xiiy), a CD20 inhibitor recently approved for adults with relapsing forms of multiple sclerosis (MS), is now commercially available in the U.S., the company announced. The treatment was approved in the U.S. late last year, with indications that include clinically isolated syndrome, relapsing-remitting MS (RRMS),…

The new year is bringing a new disease-modifying therapy (DMT) to the multiple sclerosis (MS) arsenal. Shortly after Christmas, the U.S. Food and Drug Administration (FDA) approved Briumvi (ublituximab), which joins a small group of DMTs that aim to halt MS progression by knocking out certain…

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 experimental therapy ublituximab works better than the approved treatment Aubagio (teriflunomide) at easing disability independently of relapses, and at reducing overall disease activity, in adults with relapsing forms of multiple sclerosis (MS). That’s according to exploratory analyses of pooled data from the identical ULTIMATE I…

Treatment with the experimental B-cell depleting therapy ublituximab significantly outperformed Aubagio (teriflunomide) at reducing relapse rates and the number of lesions in people with relapsing forms of multiple sclerosis (MS), according to updated data from the Phase 3 ULTIMATE clinical trials. The two medications had comparable effects…

Ublituximab, an investigational antibody-based treatment for multiple sclerosis (MS), was efficacious across most patient subgroups, and led to marked improvements in disability and quality of life over nearly two years. This is according to new exploratory analyses from the identical Phase 3 ULTIMATE I and II trials, which evaluated…

FDA Decision on Ublituximab for Relapsing MS Pushed to Year’s End Ublituximab is similar to Ocrevus (ocrelizumab) and Kesimpta (ofatumumab), which also target B-cells, the immune cells that play a role in the inflammatory attacks that harm the central nervous system of people with MS. Each of…

The U.S. Food and Drug Administration (FDA) is extending by three months its review of ublituximab, an experimental anti-CD20 antibody being developed by TG Therapeutics for relapsing forms of multiple sclerosis (MS). The FDA had agreed to review the company’s application requesting ublituximab’s approval late last year, and…

More relapsing multiple sclerosis (MS) patients given ublituximab remained relapse-free over the two-year long Phase 3 ULTIMATE clinical trials, compared to those given Aubagio (teriflunomide), new data show. “The prevention of relapses represents an important goal of disease-modifying therapy with the potential for a marked impact on the accumulation of disability,” Lawrence Steinman,…

Ublituximab, an experimental therapy for relapsing multiple sclerosis (MS) patients, outperformed Aubagio on a number of disability-related outcomes in the ULTIMATE clinical trials, new data show. The findings were presented in a series of posters at the 2022 American Academy of Neurology (AAN) Annual Meeting, being held in…

#ACTRIMS2022 – Cognitive Training Paired With tDCS Aids Patients A treatment to clear “cog fog” would be welcomed by many people with MS. Over 75% of us are troubled by cognitive problems. In this study, adding painless transcranial direct current stimulation to standard cognitive training improved results when compared…

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…

Study: Anti-CD20 Therapies, Gilenya Lower Efficacy of COVID-19 Vaccines This research adds more evidence to studies that have already shown that certain disease-modifying therapies reduce the effectiveness of COVID-19 vaccines. Those DMTs include Kesimpta (ofatumumab) and Ocrevus (ocrelizumab), plus rituximab, another anti-CD20 vaccine, that is sometimes used…

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…

Editor’s note: The Multiple Sclerosis News Today team is providing in-depth coverage of the virtual 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), Oct. 13–15. Go here to see the latest stories from the conference. The investigational anti-CD20…

Ublituximab, Potential Relapsing MS Therapy, Up for FDA Approval Like Ocrevus (ocrelizumab) and Kesimpta (ofatumumab), ublituximab targets the CD20 protein that’s found on the surface of B-cells in the immune system. It then binds to it and kills the cell, reducing the number of cells that are attacking 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…

In clinical trials, the investigational anti-CD20 therapy ublituximab was the first to push the annualized relapse rate (ARR) below the 0.1 threshold among patients with relapsing forms of multiple sclerosis (MS), while improving disability outcomes in a significant proportion of patients. “The [relapse] rate was below a tenth…

TG Therapeutics has expanded its contract with Samsung Biologics to manufacture ublituximab, an investigational therapy for relapsing forms of multiple sclerosis (MS). “Samsung is the global leader in biologics manufacturing and we are happy to have them as our partner as we look forward to the potential commercialization…

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. Ublituximab, an investigational therapy for relapsing forms of multiple sclerosis (MS), significantly outperformed Aubagio (teriflunomide) at reducing patients’…

Ublituximab, an investigational anti-CD20 antibody, outperformed Aubagio (teriflunomide) in lowering the frequency of relapses among people with active, relapsing forms of multiple sclerosis (MS), according to top-line data from the Phase 3 ULTIMATE trials. Full results, including data on safety and secondary goals, are expected to be presented…

The investigational anti-CD20 antibody ublituximab effectively depletes B-cells in people with relapsing forms of multiple sclerosis (MS), reducing the appearance of brain lesions and the risk of relapses, a study into clinical trial results suggests. Findings further suggest that the…

Ublituximab continues to be safe and well-tolerated by people with relapsing forms of multiple sclerosis (MS) after a median follow-up of 124.7 weeks — more than 2 years — according to data from an extension Phase 2 trial. The data were shown in a…

The loss of immune B-cells, and the resulting changes in the profile of immune T-cells, is a major mechanism of action for the beneficial effects seen with ublituximab treatment in multiple sclerosis (MS) patients, a study suggests. B-cells are a type of immune cell best known for producing…

Treatment with ublituximab continues to be safe and well-tolerated by patients with relapsing forms of multiple sclerosis, according to an extension study of a Phase 2 trial. According to a press release, Edward Fox, MD, PhD, from Central Texas Neurology Consultants, will give the presentation on May 7 at poster session P3: MS Clinical Trials and Therapeutic Research. Ublituximab is an investigational monoclonal antibody being developed by TG Therapeutics to target the immune B-cell marker protein CD20. This leads to the depletion of B-cells from the blood and central nervous system — B-cells are activated during MS relapses. According to the company, ublituximab may be superior to current anti-CD20 treatments in MS, enabling both lower doses and shorter infusion times. Final results of the main TG-Therapeutics-sponsored Phase 2 trial were recently presented at the 4th Annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum, held in Dallas, Texas. Data showed that 93% of the 48 patients enrolled (mean age 40 years) were relapse-free after a 48-week treatment with ublituximab. The annualized relapse rate — the number of relapses per year — was 0.07. In addition, median B-cell depletion was more than 99% throughout 48 weeks. Moreover, 87% of participants showed no evidence of clinical disease. Magnetic resonance imaging showed a complete elimination of T1 lesions at 24 and 48 weeks 24 in all 46 patients analyzed. Mean T2 lesion volume decreased by 10.6% at 48 weeks, compared with the beginning of the study. T1 lesions refer to areas of active inflammation and disease activity, while T2 lesions are a measure of the total amount of lesions, both old and new. Ublituximab was found to be well-tolerated, and did not induce an severe treatment-related adverse events. The most frequent adverse events were infusion-related reactions. No patient had to discontinue treatment due to an ublituximab-related side effect. At the upcoming AAN meeting, Fox will present data on both this Phase 2 trial and its open-label extension, in which 37 patients from the primary study continued receiving one-hour infusions of 450 mg of ublituximab every 24 weeks for an additional 96 weeks. Safety was monitored throughout the study, and disability assessments using the Expanded Disability Status Scale were conducted every 48 weeks. As of October 2018, nearly 30% of participants had completed 48 weeks of treatment in the extension study. Results showed that ublituximab continues to be well-tolerated, with no discontinuations due to adverse events. “The Phase 2 OLE supports that one-hour infusions of [ublituximab] continue to be safe and well tolerated,” the researchers wrote. Of note, five of the eight study authors are affiliated with TG Therapeutics. The team expects additional patient follow-up data from the study to be available by the time of the AAN presentation. According to the scientists, the results support the ongoing Phase 3 ULTIMATE program, which includes the ULTIMATE 1 and ULTIMATE 2 trials. These studies are comparing the efficacy and safety of 450 mg of ublituximab with Aubagio over 96 weeks of treatment in relapsing MS patients. Both trials are led by Lawrence Steinman, MD, at Stanford University. TG Therapeutics expects to have results from these trials as early as mid-2020.

Full results of a Phase 2 clinical trial testing TG Therapeutics’ lead candidate ublituximab (TG-1101) for relapsing multiple sclerosis (MS) showed that treatment for 48 weeks resulted in a marked reduction of brain and spinal cord lesions, an almost complete depletion of relapse-associated immune B-cells, and significantly halted disability…

A 48-week treatment of relapsing multiple sclerosis (MS) with TG Therapeutics’ investigational compound ublituximab led to a marked reduction of brain and spinal cord lesions, massive depletion of relapse-associated immune B-cells, and significantly halted disability progression, according to results from a Phase 2 clinical trial. The data…

TG Therapeutics announced it has reached target enrollment in the ULTIMATE I and II Phase 3 clinical trials assessing the use of ublituximab (TG-1101) to treat relapsing forms of multiple sclerosis (MS). Ublituximab is a modified anti-CD20 monoclonal antibody, which is designed to target a protein present on mature…

New results from a Phase 2 trial evaluating TG Therapeutics’ ublituximab continue to support the therapy’s efficacy in treating relapsing forms of multiple sclerosis (MS). This investigative infusion therapy is now moving into a Phase 3 study. Treatment with 450 mg of ublituximab delivered intravenously in a rapid fashion…

TG Therapeutics‘ ublituximab (TG-1101) led to a remarkable reduction in multiple sclerosis patients’ brain and spine lesions, a Phase 2 clinical trial showed. In fact, none of the treated patients had new gadolinium-enhancing lesions — or damaged nerve cell areas — six months after treatment, researchers said. Their analysis covered patients…