April 22, 2024 News by Marisa Wexler, MS AAN 2024: Briumvi found to ease disability in certain MS patients 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,…
March 8, 2024 News by Andrea Lobo, PhD Briumvi, an infusion treatment for MS, granted 3 more patents 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…
March 8, 2024 News by Margarida Maia, PhD ACTRIMS 2024: Switch to Briumvi well tolerated in relapsing MS 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…
February 29, 2024 News by Andrea Lobo, PhD Briumvi for relapsing MS now available for patients in Europe Briumvi (ublituximab-xiiy), an approved treatment for relapsing forms of multiple sclerosis (MS), is now available to patients in Europe, where itās 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…
August 3, 2023 News by Patricia Inacio, PhD New deal grants Neuraxpharm rights to market Briumvi in Europe 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…
June 2, 2023 News by Marisa Wexler, MS Briumvi approved in Europe for active, relapsing forms of MS 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,…
May 2, 2023 News by Andrea Lobo, PhD Briumvi’s permanent J-code will aid reimbursement for MS patients 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…
April 4, 2023 News by Margarida Maia, PhD CHMP favors Briumvi for approval to treat relapsing forms of MS in EU 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 theĀ European Union (EU). The Committee for Medicinal Products for Human Use (CHMP) opinion is based on data from twin Phase 3 trials,…
March 20, 2023 News by Patricia Inacio, PhD Half of US neurologists expect to test Briumvi in the next 6 months 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,Ā according to anĀ analysisĀ by market research companyĀ Spherix Global Insights. The therapy, developed…
March 3, 2023 News by Marisa Wexler, MS ACTRIMS 2023: TG aims to make Briumvi accessible to patients 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…
March 2, 2023 News by Marisa Wexler, MS ACTRIMS 2023: Most on Briumvi show no MS activity after 6 months 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 ā and over 80% of participants had no disease activity for the…
January 27, 2023 News by Patricia Inacio, PhD 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),…
January 6, 2023 Columns by Ed Tobias 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…
December 28, 2022 News by Lindsey Shapiro, PhD 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…