Briumvi FDA Approval History
Last updated by Judith Stewart, BPharm on Dec 29, 2022.
FDA Approved: Yes (First approved December 28, 2022)
Brand name: Briumvi
Generic name: ublituximab-xiiy
Dosage form: Injection
Company: TG Therapeutics, Inc.
Treatment for: Multiple Sclerosis
Briumvi (ublituximab-xiiy) is a CD20-directed cytolytic antibody 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 a CD20-directed monoclonal antibody that works to slow disease progression in relapsing multiple sclerosis by depleting immune B-cells. CD20 is a protein found on the surface of the B-cells, and when Briumvi binds to the B-cell, it triggers a series of immunological reactions that leads to the destruction of the B-cell.
- Briumvi is administered by intravenous infusion. The second infusion is given two weeks after the first infusion, and subsequent infusions are administered every 24 weeks.
- Warnings and precautions associated with Briumvi include infusion reactions, increased risk of infections, reduction in immunoglobulin levels, and fetal harm.
- Common adverse reactions include infusion reactions and upper respiratory tract infections.
Development timeline for Briumvi
| Date | Article |
|---|
| Dec 28, 2022 | Approval FDA Approves Briumvi (ublituximab-xiiy) for the Treatment of Relapsing Forms of Multiple Sclerosis |
| Aug 25, 2022 | TG Therapeutics Announces Results from the ULTIMATE I & II Phase 3 Trials of Investigational Ublituximab in RMS Published in The New England Journal of Medicine |
| May 31, 2022 | TG Therapeutics Announces FDA Extension of BLA PDUFA Date for Ublituximab to Treat Patients with RMS |
| Mar 3, 2022 | TG Therapeutics Announces Extension of U.S. FDA BLA/sNDA PDUFA Date for Ublituximab Plus UKONIQ® (U2) to Treat Patients with CLL and SLL |
| May 25, 2021 | TG Therapeutics Announces FDA Acceptance of Biologics License Application for Ublituximab in Combination with Ukoniq (umbralisib) as a Treatment for Patients with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma |
| Mar 29, 2021 | TG Therapeutics Completes Rolling Submission of Biologics License Application to the U.S. Food and Drug Administration for Ublituximab in Combination with Ukoniq (umbralisib) as a Treatment for Patients with Chronic Lymphocytic Leukemia |
| Dec 1, 2020 | TG Therapeutics Initiates Rolling Submission of Biologics License Application to U.S. Food and Drug Administration for Ublituximab in Combination with Umbralisib as a Treatment for Patients with Chronic Lymphocytic Leukemia |
| May 5, 2020 | TG Therapeutics Announces Positive Topline Results from the UNITY-CLL Phase 3 Study Evaluating the Combination of Umbralisib and Ublituximab (U2) for the Treatment of Patients with Chronic Lymphocytic Leukemia |
| May 1, 2020 | TG Therapeutics Announces Publication of Ublituximab Phase 2 Clinical Trial Results in Multiple Sclerosis Journal |
| Oct 16, 2017 | TG Therapeutics Provides Update on FDA Meeting for TG-1101 (ublituximab) GENUINE Phase 3 Trial |
| Aug 1, 2017 | TG Therapeutics Announces Special Protocol Assessment (SPA) Agreement with the FDA for a Phase 3 Program of TG-1101 (ublituximab) for Patients with Multiple Sclerosis (MS) |
| Jun 26, 2017 | TG Therapeutics Recaps Preliminary Results from Ongoing Phase 2 Study of TG-1101 (ublituximab) in Patients with Multiple Sclerosis at the 3rd Congress of the European Academy of Neurology |
Further information
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