A Biologics License Application has been submitted to the Food and Drug Administration (FDA) for ublituximab for the treatment of patients with relapsing forms of multiple sclerosis.
Ublituximab is an investigational glycoengineered monoclonal antibody that targets CD20, a cell surface antigen present on pre-B and mature B lymphocytes. Following cell surface binding to B lymphocytes, ublituximab results in antibody-dependent cellular cytotoxicity and complement-mediated cytotoxicity. Glycoengineering is expected to enhance the potency of ublituximab.
The application is supported by data from 2 identical, randomized, double-blind, active-controlled phase 3 trials, ULTIMATE 1 (ClinicalTrials.gov Identifier: NCT03277261) and ULTIMATE 2 (ClinicalTrials.gov Identifier: NCT03277248). These studies compared the efficacy and safety of ublituximab to teriflunomide in patients with relapsing multiple sclerosis.
Patients were randomly assigned to receive either ublituximab 150mg via intravenous infusion on day 1 and 450mg on day 15 followed by a 450mg dose every 6 months or teriflunomide 14mg orally once daily. Results from both trials showed that treatment with ublituximab demonstrated a statistically significant reduction in annualized relapse rate over a 96-week period compared with teriflunomide (P <.005 in each trial).
Trial data will be presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) being held virtually October 13 to 15, 2021.
- TG Therapeutics submits Biologics License Application to the US Food and Drug Administration for ublituximab as a treatment for patients with relapsing forms of multiple sclerosis. News 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-U-S-Food-and-Drug-Administration-for-Ublituximab-as-a-Treatment-for-Patients-with-Relapsing-Forms-of-Multiple-Sclerosis.html.
- TG Therapeutics announces data presentations from the ULTIMATE I & II phase 3 trials of ublituximab in multiple sclerosis to be presented at 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis. News 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.