Neurological

Ublituximab BLA submitted for relapsing forms of multiple sclerosis

Subjects ” multiple sclerosis

Ublituximab, for the treatment of patients with relapsing multiple sclerosis, has filed for approval with the Food and Drug Administration (FDA) for biologics.

Ublituximab is an under investigation, glyco-engineered monoclonal antibody that targets CD20, a cell surface antigen present on pre-B and mature B lymphocytes. After binding to B lymphocytes on the cell surface, ubituximab leads to antibody-dependent cellular cytotoxicity and complement-mediated cytotoxicity. Glycoengineering is expected to increase the effectiveness of ubituximab.

Use is supported by data from 2 identical, randomized, double-blind, actively controlled Phase 3 studies, ULTIMATE 1 (ClinicalTrials.gov Identifier: NCT03277261) and ULTIMATE 2 (ClinicalTrials.gov Identifier: NCT03277248). These studies compared the efficacy and safety of ubituximab with teriflunomide in patients with relapsing multiple sclerosis.

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Patients were randomly given either ubituximab 150 mg as an intravenous infusion on day 1 and 450 mg on day 15, followed by a dose of 450 mg every 6 months or teriflunomide 14 mg orally once daily. The results of both studies showed that treatment with ubituximab for 96 weeks showed a statistically significant reduction in the annualized relapse rate compared to teriflunomide (P <0.005 in each study).

The study data will be presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), which will take place virtually from October 13-15, 2021.

References

  1. TG Therapeutics is filing a biologics application for Ublituximab for the treatment of patients with relapsing multiple sclerosis with the US Food and Drug Administration. Press release. TG Therapeutics, Inc. Accessed September 30, 2021. https://www.globenewswire.com/news-release/2021/09/30/2306091/8790/en/TG-Therapeutics-Submits-Biologics-License-Application- to -the-US-Food-and-Drug-Administration-for-Ublituximab-as-a-treatment-for-patients-with-recurrent-forms-of-multiple-sclerosis.html.
  2. TG Therapeutics Announces Data Presentations for Phase 3 ULTIMATE I & II Studies of Ublituximab in Multiple Sclerosis to be presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis. Press release. TG Therapeutics, Inc. Accessed September 30, 2021. https://ir.tgtherapeutics.com/news-releases/news-release-details/tg-therapeutics-announces-data-presentations-ultimate-i-ii-phase.

This article originally appeared on MPR

Subjects:

Multiple sclerosis Recurrent remitting multiple sclerosis

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More information submitted on ubituximab BLA for relapsing multiple sclerosis

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More information submitted on ubituximab BLA for relapsing multiple sclerosis

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