Ublituximab, Potential Relapsing MS Therapy, Up for FDA Approval

Ublituximab, Potential Relapsing MS Therapy, Up for FDA Approval

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Ublituximab, Potential Relapsing MS Therapy, Up for FDA Approval

TG Therapeutics  has applied to the U.S. Food and Drug Administration (FDA) for approval of ublituximab, the company’s investigational anti-CD20 monoclonal antibody therapy for relapsing forms of multiple sclerosis (RMS). Its application was based on data from the ULTIMATE 1 (NCT03277261) and ULTIMATE 2 (NCT03277248) Phase 3 studies that demonstrated ublituximab was superior to the approved therapy Aubagio (teriflunomide) in lowering the frequency of MS relapses over two years. “The submission of this BLA [biologics license…

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