ublituximab

Relapsing MS Therapy Briumvi Now Commercially Available in US

TG Therapeutics’ Briumvi (ublituximab-xiiy), a CD20 inhibitor recently approved for adults with relapsing forms of multiple sclerosisĀ (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 includeĀ clinically isolated syndrome,Ā relapsing-remitting MS (RRMS),…

FDA Approval of Ublituximab, Now Briumvi, Is Good News

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…

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 MSĀ (RRMS), andĀ active secondary progressive…

#AAN2022 ā€“ More Patients Given Ublituximab Relapse-free in Trials

More relapsingĀ multiple sclerosisĀ (MS) patients givenĀ ublituximabĀ remained relapse-free over the two-year long Phase 3 ULTIMATE clinical trials, compared to those givenĀ AubagioĀ (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,…

#AAN2022 ā€“ Ublituximab Bests Aubagio on Disability Measures

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…

Ublituximab as Relapsing MS Therapy Under FDA Review

The U.S. Food and Drug Administration (FDA) has agreed to review TG Therapeuticsā€™ application seeking the approval of ublituximab as a treatment for people with relapsing forms ofĀ multiple sclerosis. An FDAā€™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 TherapeuticsĀ  has applied to the U.S. Food and Drug Administration (FDA) for approval ofĀ ublituximab, the companyā€™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…

TG Expands Contract With Samsung Biologics to Produce Ublituximab

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…

#AANAM ā€“ Ublituximab Reduced Relapse Rate, Disability Progression in Twin Trials

Editorā€™s note: TheĀ Multiple Sclerosis News TodayĀ team is providing in-depth coverage of the 2021 Virtual AAN Annual Meeting, April 17ā€“22. GoĀ hereĀ 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’…

#AANAM – Ublituximab Safe, Well-tolerated in Extension Study of Phase 2 Trial in Relapsing MS

Treatment withĀ 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 ā€” 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 4thĀ 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 ā€” the number of relapses per year ā€” was 0.07. In addition, median B-cell depletion was more than 99% throughout 48 weeks.Ā 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 andĀ 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 theĀ Expanded Disability Status ScaleĀ 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. ā€œThe Phase 2 OLE supports that one-hour infusions of [ublituximab] continue to be safe and well tolerated,ā€ 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 withĀ AubagioĀ over 96 weeks of treatment in relapsing MS patients.Ā Both trials are led byĀ Lawrence Steinman, MD, atĀ Stanford University. TG Therapeutics expects toĀ have results from these trials as early as mid-2020.

#ACTRIMS2019 – TG Therapeutics’ Investigational Therapy Ublituximab Posts Positive Data in MS Phase 2 Clinical Trial

Full results of a Phase 2 clinical trial testing TG Therapeuticsā€™ lead candidate ublituximab (TG-1101) for relapsingĀ multiple sclerosisĀ (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…

#ECTRIMS2018 – Ublituximab Markedly Reduces Lesions, Promotes B-cell Depletion, Halts Disability Progression in Phase 2 Trial

A 48-week treatment of relapsing multiple sclerosis (MS) with TG Therapeuticsā€™ 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…

#ACTRIMS2018 – Ublituximab Led to Major Drop in MS Brain and Spine Lesions, Trial Shows

TG Therapeutics‘ ublituximab (TG-1101) led toĀ 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 ā€” or damaged nerve cell areas ā€” six months after treatment, researchers said.Ā Their analysis covered patients…