On Dec. 28, 2022, TG Therapeutics was granted approval from the U.S. Food and Drug Administration (FDA) for Briumvi™ (ublituximab-xiiy) injection. Administered intravenously (IV) twice a year after a loading dose, it is approved to treat adults who have relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome (CIS), relapsing-remitting disease (RRMS) and active secondary progressive disease (SPMS). The recommended initial dose is 150mg delivered over four hours. The second dose is given two weeks later as a one-hour-long 450mg infusion, followed by the same dose and rate once every 24 weeks. A monoclonal antibody that has been modified to achieve effectiveness at low doses, Briumvi attaches to CD20 on B cells and decreases nerve damage. The launch is planned for the first quarter of 2023; pricing information has not yet been released. Look here for complete prescribing information.
At a Glance
- Brand (Generic) Name: Briumvi (ublituximab-xiiy)
- Manufacturer: TG Therapeutics
- Date Approved: Dec. 28, 2022
- Indication: for the treatment of adults who have relapsing forms of MS, including CIS, RRMS, and active SPMS
- Dosage Forms Available: single-dose vials of 150mg/6mL for dilution and IV infusion
- Launch Date: First quarter 2023
- Estimated Annual Cost: Pricing information is not yet available.
- MS is an autoimmune condition that damages myelin sheaths protecting nerve cells. It usually is characterized by random periods of symptom flares (relapses) interspersed with recovery (remissions) and plateaus.
- Most commonly diagnosed between the ages of 20 years and 50 years old, MS affects about one million patients in the United States.
- Approximately three times as many women as men have it, and MS strikes more Caucasians than members of other races, as well as more individuals living in northern locations than southern ones.
- Around 85% of patients initially have RRMS, but most ultimately progress to SPMS, which has few relapses and more periods of steadily worsening symptoms.
- Briumvi is a monoclonal antibody that has been altered (glycoengineered) to eliminate some sugar molecules – making it fit more closely into receptors and increasing its effectiveness. It attaches to specific points on the CD20 antigen, which is expressed by B cells in the mid-stages of their development. The numbers of B cells, which are overactive or dysfunctional in MS, are decreased, reducing damage to myelin and nerve cells.
- In two 96-week-long phase III clinical trials, Briumvi was compared to Aubagio® (teriflunomide) tablets, an oral pyrimidine synthesis inhibitor that is taken once a day to treat relapsing forms of MS. The average relapse rate decreased by 59% in one study (0.076 vs 0.188) and 49% in the other one (0.091 vs 0.178) for patients in the Briumvi group as compared with those taking Aubagio. Across both studies, 5.2% of Briumvi-treated participants had confirmed disability progression at 12 weeks as opposed to 5.9% of patients on Aubagio. Both groups had similar relative reductions in MRI-identified lesions (97%) and average decreases in new lesions (about 90%).
- Because nearly one-half of patients receiving Briumvi had infusion reactions, patients should be observed for one hour or longer following at least the first two infusions to be sure no problems arise.
- One patient experienced a reactivation of hepatitis B (HBV) when treated with Briumvi, so all patients should be tested for HBV before beginning treatment with it.
- Ocrevus® (ocrelizumab – Genentech) and Kesimpta® (ofatumumab – Novartis), two other monoclonal antibodies that block CD20, treat MS in ways similar to the ways that Briumvi does. Ocrevus is administered by IV infusions once every six months after two smaller doses are given two weeks apart. Kesimpta is a subcutaneous (SC) injection spaced at one-month intervals following three doses at the first, second and third weeks. It can be self-administered.