TG Therapeutics announces that ubrituximab (Briumvi), a monoclonal antibody that targets CD20, has been shown to treat relapsing multiple sclerosis, including clinically isolated syndromes, relapsing-remitting disease, and active secondary progressive disease. announced that it has been approved for MS.
The FDA’s decision is based on two identical Phase III trials, ULTIMATE I and ULTIMATE II, in patients with relapsed MS.
Lawrence Steinman, MD, Stanford University, Palo Alto, Calif., found that ublituximab had a 59% reduction in annual recurrence rate (ARR) at 96 weeks over teriflunomide (Aubagio) with ULTIMATE I and a 49% reduction with ULTIMATE II over teriflunomide. Reported. His 2021 Conference of the European Commission for Multiple Sclerosis Treatment and Research (ECTRIMS).
The mean number of gadolinium-enhancing lesions was 0.02 for ubrituximab vs. 0.49 for teriflunomide for ULTIMATE I and 0.01 vs. 0.25 for ULTIMATE II, respectively. The test results are then New England Journal of Medicine.
“Over the past few years, we have seen a dramatic shift in the MS treatment landscape towards the use of B-cell therapies that have been shown to be highly effective in reducing patient relapses. I got
ULTIMATE I and II represent an important milestone in the history of MS research, as “the first Phase III trial of an anti-CD20 monoclonal antibody in patients with relapsing MS, representing an annual relapse rate of less than 0.10, or less than 1 It will recur in 10 years,” he added.
Ubrituximab is a glycoengineering drug that binds to B cells and triggers a range of immune responses including antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity leading to cell destruction. The drug is designed to lack specific sugar molecules that are normally expressed on antibodies and may enhance ADCC activity.
In a pooled analysis of the ULTIMATE trial, the most common adverse events in ubrituximab recipients were infusion-related reactions (47.7%), headache (34.3%), nasopharyngitis (18.3%), pyrexia (13.9%), nausea ( 10.6%). ).
Serious infections occurred in 5.0% of patients in the ubrituximab group. One death each from pneumonia, post-measles encephalitis and salpingitis after ectopic pregnancy occurred in patients receiving ubrituximab.
No case of progressive multiple leukoencephalopathy (PML) seen over 96 weeks, but John Cunningham polyoma virus (JCV) leading to PML in patients treated with other anti-CD20 antibodies and other MS therapies Antibodies were observed, TG Therapeutics said. MRI findings indicative of PML may be evident prior to clinical symptoms, and monitoring for signs consistent with PML may be useful, the company added.
This drug is contraindicated in MS patients with active hepatitis B virus infection and in patients with a history of life-threatening infusion reactions to ubrituximab.
TG Therapeutics said it expects the drug to be available in the first quarter of 2023.