Neurological

Ublituximab is being examined for relapsing forms of multiple sclerosis

Subjects ” multiple sclerosis

The Food and Drug Administration (FDA) has accepted a biologic submission for ubituximab for the treatment of patients with relapsing multiple sclerosis.

Ublituximab is an investigational glycotechnically engineered monoclonal antibody that targets CD20, a cell surface antigen present on pre-B and mature B lymphocytes. 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. 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.

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The results of both studies showed that treatment with ubituximab for 96 weeks compared to teriflunomide (primary endpoint) showed a statistically significant reduction in the annualized relapse rate (ARR). In ULTIMATE I, treatment with ubituximab resulted in an ARR of 0.076 vs. 0.188 for teriflunomide, which corresponds to a relative reduction of about 60% (P <0.0001). In ULTIMATE II, treatment with blituximab resulted in an ARR of 0.091 vs. 0.178 for teriflunomide, a relative reduction of about 50% (P = 0.0022).

According to the company, there will not be a meeting of the FDA advisory committee to consider the application. The agency has set the target date for 28.

References

  1. TG Therapeutics announces that the FDA has accepted biologics filing for ubituximab for the treatment of patients with relapsing multiple sclerosis. Press release. December 14, 2021. https://www.globenewswire.com/news-release/2021/12/14/2351552/8790/en/TG-Therapeutics-Announces-FDA-Acceptance-of-Biologics-License-Application-for -Ublituximab-as-a-treatment-for-patients-with-recurrent-forms-of-multiple-sclerosis.html.
  2. TG Therapeutics Announces Data on Ublituximab in Multiple Sclerosis, Presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis. Press release. October 14, 2021. https://ir.tgtherapeutics.com/news-releases/news-release-details/tg-therapeutics-announces-data-ublituximab-multiple-sclerosis.

This article originally appeared on MPR

Subjects:

multiple sclerosis

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