• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Directories » FDA Approved Drugs » Briumvi (ublituximab-xiiy)

AND
  • A
  • B
  • C
  • D
  • E
  • F
  • G
  • H
  • I
  • J
  • K
  • L
  • M
  • N
  • O
  • P
  • Q
  • R
  • S
  • T
  • U
  • V
  • W
  • X
  • Y
  • Z

Briumvi (ublituximab-xiiy)

  • Profile

Profile

Contact Information

Contact: TG Therapeutics
Website: https://briumvi.com/

Currently Enrolling Trials

    Show More

    General Information

    Briumvi (ublituximab-xiiy) is a CD20-directed cytolytic antibody.

    Briumvi is specifically indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

    Briumvi is supplied as a solution for intravenous administration. 

    • HBV reactivation occurred in an MS patient treated with Briumvi in clinical trials. Hepatitis B virus screening and quantitative serum immunoglobulin screening are required before first dose. 
    • Pre-medicate with methylprednisolone (or an equivalent corticosteroid) and an antihistamine (e.g., diphenhydramine) prior to each infusion.

    Briumvi must be diluted in 0.9% Sodium Chloride Injection, USP prior to administration

    • First Infusion: 150 mg intravenous infusion
    • Second Infusion: 450 mg intravenous infusion two weeks after the first infusion
    • Subsequent Infusions: 450 mg intravenous infusion 24 weeks after the first infusion and every 24 weeks thereafter

    Monitor patients closely during and for at least one hour after the completion of the first two infusions. Post-infusion monitoring of subsequent infusions is at physician discretion unless infusion reaction and/or hypersensitivity has been observed

    Mechanism of Action

    The precise mechanism by which ublituximab-xiiy exerts its therapeutic effects in multiple sclerosis is unknown, but is presumed to involve binding to CD20, a cell surface antigen present on pre-B and mature B lymphocytes. Following cell surface binding to B lymphocytes, ublituximab-xiiy results in cell lysis through mechanisms including antibody-dependent cellular cytolysis and complement-dependent cytolysis.

    Side Effects

    The most common adverse reactions associated with the use of Briumvi include infusion reactions and upper respiratory tract infections. 

    Clinical Trial Results

    The FDA approval of Briumvi was based on the ULTIMATE I & II randomized, double-blind, double-dummy, parallel group, active comparator-controlled clinical trials of identical design, in patients with RMS treated for 96 weeks. Patients were randomized to receive either Briumvi, given as an IV infusion of 150 mg administered in four hours, 450 mg two weeks after the first infusion administered in one hour, and 450 mg every 24 weeks administered in one hour, with oral placebo administered daily; or teriflunomide, the active comparator, given orally as a 14 mg daily dose with IV placebo administered on the same schedule as Briumvi . Both studies enrolled patients who had experienced at least one relapse in the previous year, two relapses in the previous two years, or had the presence of a T1 gadolinium (Gd)-enhancing lesion in the previous year. Patients were also required to have an Expanded Disability Status Scale (EDSS) score from 0 to 5.5 at baseline. The ULTIMATE I & II trials enrolled a total of 1,094 patients with RMS across 10 countries. 

    The primary endpoint of both trials was the Annualized Relapse Rate (ARR)

    • In ULTIMATE I, treatment with ublituximab resulted in an ARR of 0.08 (n=271), compared to 0.19 for teriflunomide (n=274).

    • In ULTIMATE II, treatment with ublituximab resulted in an ARR of 0.09 (n=272), compared to 0.18 for teriflunomide (n=272).

    • Briumvi also demonstrated superiority over teriflunomide in significantly reducing the number of T1 Gd-enhancing lesions and the number of new or enlarging T2 lesions

    Approval Date: 2022-12-01
    Company Name: TG Therapeutics
    Back to Listings

    Upcoming Events

    • 16Feb

      Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

    • 21May

      WCG MAGI Clinical Research Conference – 2023 East

    Featured Products

    • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

      Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    • Surviving an FDA GCP Inspection

      Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

    Featured Stories

    • SurveywBlueBackground-360x240.png

      Sites Name Tech Acceptance as Essential Factor in Selection of Sponsors, Survey Finds

    • TrendsInsights2023-360x240.png

      WCG Clinical Research Trends and Insights for 2023, Part Two

    • TimeMoneyEffort-360x240.png

      Time is Money and So Is Effort, Budgeting Experts Say

    • TrendsInsights2023A-360x240.png

      WCG Clinical Research Trends and Insights for 2023, Part Three

    Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

    The information you need to adapt your monitoring plan to changing times.

    Learn More Here
    • About Us
    • Contact Us
    • Privacy Policy
    • Do Not Sell or Share My Data

    Footer Logo

    300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

    Phone 617.948.5100 – Toll free 866.219.3440

    Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing