The Food and Drug Administration (FDA) has accepted the Biologics License Application 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. 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 (ARR) over a 96-week period compared with teriflunomide (primary endpoint). In ULTIMATE I, treatment with ublituximab resulted in an ARR of 0.076 vs 0.188 for teriflunomide, representing a relative reduction of approximately 60% (P <.0001). In ULTIMATE II, treatment with ublituximab resulted in an ARR of 0.091 vs 0.178 for teriflunomide, representing a relative reduction of approximately 50% (P =.0022).
According to the Company, an FDA advisory committee meeting will not be held to review the application. The Agency has provided a Prescription Drug User Fee Act (PDUFA) target date of September 28, 2022.
- TG Therapeutics announces FDA acceptance of Biologics License Application for ublituximab as a treatment for patients with relapsing forms of multiple sclerosis. News 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-Relapsing-Forms-of-Multiple-Sclerosis.html.
- TG Therapeutics announces data for ublituximab in multiple sclerosis presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis. News release. October 14, 2021. https://ir.tgtherapeutics.com/news-releases/news-release-details/tg-therapeutics-announces-data-ublituximab-multiple-sclerosis.