Enrollment is complete for the randomized part of ENHANCE, a large clinical trial testing a new dosing schedule for Briumvi (ublituximab-xiiy) in adults with relapsing forms of multiple sclerosis (MS), developer TG Therapeutics announced. This part of the Phase 3b ENHANCE study (NCT05877963) is specifically testing whether…
briumvi
Up to six years of continuous treatment with Briumvi (ublituximab) led to sustained reductions in relapse rates and a low rate of disability progression in people with relapsing forms of multiple sclerosis (MS), with no new safety concerns reported. That’s according to new long-term data from the…
TG Therapeutics has started enrolling participants in a Phase 3 trial to test a new version of Briumvi (ublituximab-xiiy) that can be injected at home. This change could offer greater convenience and flexibility for people with relapsing forms of multiple sclerosis (MS). The new formulation is given…
The CD20 inhibitor Ocrevus (ocrelizumab) rapidly depletes immune B-cells in people with multiple sclerosis (MS), as expected, but ongoing treatment also leads to changes in immune T-cells, a new study reports. After about six months of treatment, patients experience T-cell changes such as an increase in regulatory…
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…
A Phase 4 observational study called ENABLE is enrolling adults with relapsing forms of multiple sclerosis (MS) across the U.S. to better understand the safety, tolerability, and efficacy of Briumvi (ublituximab-xiiy) in the real world. At least 500 patients are expected to enter ENABLE (NCT06433752) at some…
People with multiple sclerosis (MS) who receive anti-CD20 therapies such as Ocrevus (ocrelizumab) are significantly less likely to discontinue their treatment compared with patients who are given other disease-modifying therapies (DMTs), a Swiss study has found. Staying on treatment may be related to the effectiveness of B-cell-depleting…
TG Therapeutics is working to develop a subcutaneous, or under-the-skin, version of Briumvi (ublituximab-xiiy), its approved therapy for relapsing forms of multiple sclerosis (MS). The company said it plans to start a pivotal clinical program this year which could support an application seeking approval of the…
Continuous treatment with Briumvi (ublituximab) over five years was associated with low rates of relapses and confirmed disability progression among people with relapsing forms of multiple sclerosis (MS), according to analyses from the open-label extension (OLE) phase of the treatment’s ULTIMATE Phase 3 trials. Relative to patients who…
TG Therapeutics is conducting two post-marketing studies to determine how safe Briumvi (ublituximab-xiiy) is among people with relapsing forms of multiple sclerosis (MS) who are pregnant or breastfeeding, as well as their babies. The goal is to generate data on the use of Briumvi during pregnancy and lactation…
An abnormally active metabolism in immune B-cells can trigger the release of pro-inflammatory signaling molecules that drive further inflammation in multiple sclerosis (MS), a study found. Selectively blocking certain metabolic processes with a Bruton’s tyrosine kinase (BTK) inhibitor normalized B-cell metabolism and shifted their signaling to an anti-inflammatory state.
Two years of treatment with Briumvi (ublituximab) in clinical trials resulted in a confirmed reduction in disability for more than 1 in 10 people with early relapsing multiple sclerosis (MS) who had not received any prior treatment. That’s according to new data from the ULTIMATE Phase 3 trials,…
TG Therapeutics has secured three additional U.S. patents for Briumvi (ublituximab-xiiy), an anti-CD20 antibody that’s been approved to treat relapsing forms of multiple sclerosis (MS). Issued by the U.S. Patent and Trademark Office, the patent numbers 11,807,689; 11,814,439; and 11,884,740 specifically cover the composition and…
People with relapsing forms of multiple sclerosis (MS) being treated with an infusion CD20 inhibitor such as Ocrevus (ocrelizumab) can safely transition to the more recent Briumvi (ublituximab-xiiy), which is given in shorter infusion times. That’s according to data from the ENHANCE Phase 3b clinical trial…
Briumvi (ublituximab-xiiy), an approved treatment for relapsing forms of multiple sclerosis (MS), is now available to patients in Europe, where it’s being marketed by Neuraxpharm. The infusion therapy, developed by TG Therapeutics, was first launched in Germany, with additional rollouts following in other European countries. Under…
People with multiple sclerosis (MS) of African descent had higher levels of inflammatory B-cells in the fluid around the brain and spinal cord compared with white MS patients in a small U.S. study. These findings may help to explain why Black people with MS tend to experience a faster…
The specialty pharmaceutical company Neuraxpharm will be responsible for marketing the multiple sclerosis (MS) therapy Briumvi (ublituximab) in regions outside the U.S., Canada, Mexico, and certain Asian countries as part of a new collaboration with TG Therapeutics worth $140 million in upfront payments alone. Neuraxpharm is…
Welcome to “MS News Notes,” a Monday morning column where I comment on multiple sclerosis (MS) news stories that caught my eye last week. Here’s a look at what’s been happening: Is CD40L a better way to control MS inflammation? CD40L is a protein that’s involved with activation of…
The European Commission has approved Briumvi (ublituximab) for the treatment of adults with relapsing forms of multiple sclerosis (MS) who have active disease, as defined by clinical or imaging features. The approval, which covers all member states in the European Union, as well as Iceland, Norway, and Liechtenstein,…
Welcome to “MS News Notes,” a Monday morning column where I comment on multiple sclerosis (MS) news stories that caught my eye last week. Here’s a look at what’s been happening: Study: Starting Ocrevus early is better than later The MS News Today story “AAN 2023: Early…
The recently approved CD20 inhibitor Briumvi (ublituximab-xiiy) has received a permanent insurance reimbursement code that will simplify claims submissions and documentation processes for adults in the U.S. with relapsing forms of multiple sclerosis who are prescribed it. Issued by the U.S. Centers for Medicare and Medicaid Services, the…
An arm of the European Medicines Agency favors the approval of Briumvi (ublituximab) to treat adults with active, relapsing forms of multiple sclerosis (MS) across the European Union (EU). The Committee for Medicinal Products for Human Use (CHMP) opinion is based on data from twin Phase 3 trials,…
Note: This column was updated March 30, 2023, to remove the statement that Briumvi is more potent than Ocrevus or Kesimpta as there have been no trials comparing the three therapies’ potency. Welcome to “MS News Notes,” a Monday morning column in which I comment on multiple sclerosis (MS)…
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…
Welcome to “MS News Notes,” a Monday morning column in which I comment on multiple sclerosis (MS) news stories that caught my eye last week. In this column, I’ll be highlighting more MS News Today articles from the Americas Committee for Treatment and Research in Multiple Sclerosis…
Briumvi (ublituximab-xiiy) recently became the third anti-CD20 monoclonal antibody to be approved by the U.S. Food and Drug Administration (FDA) as a treatment for relapsing forms of multiple sclerosis (MS). TG Therapeutics, the therapy’s developer, is now aiming to make Briumvi the most accessible therapy in its…
More than half of the people with relapsing forms of multiple sclerosis (MS) who received Briumvi (ublituximab) in the ULTIMATE clinical trials had no signs of disease activity over the first six months of the trial — and over 80% of participants had no disease activity for the…
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…