TG Therapeutics announced the submission of a Biologics License Application to the FDA for approval of ublituximab, according to a press release by TG Therapeutics on Thursday.
- Ublituximab is an investigational glycoengineered monoclonal antibody that targets a specific epitope on CD-20 expressing B-cells, as a treatment for patients with recurring forms of multiple sclerosis (RMS).
- The submission for the drug’s approval was based on the outcomes of the ULTIMATE I & II trials, two similar Phase 3, randomized, active-controlled trials assessing ublituximab compared to teriflunomide in patients with multiple sclerosis.
- Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics stated that the request for BLA for ublituximab is a major milestone for the company.
- The submission was their first marketing application of an autoimmune indication and completed their near-term US regulatory submissions.
Weiss further stated that the company created a new treatment method for patients diagnosed with multiple sclerosis, which affects nearly 1 million Americans.
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