Posted by Michael Wonder on 01 Oct 2021
TG Therapeutics submits biologics license application to the U.S. FDA for ublituximab as a treatment for patients with relapsing forms of multiple sclerosis
30 September 2021 - TG Therapeutics today announced the submission of a biologics license application to the U.S. FDA requesting approval of ublituximab, the Company’s investigational glycoengineered anti-CD20 monoclonal antibody, as a treatment for patients with relapsing forms of multiple sclerosis.
The submission was based on the results of the ULTIMATE I & II trials, two identical Phase 3, randomised, global, multi-center, double-blinded, active-controlled trials evaluating ublituximab compared to teriflunomide in patients with relapsing forms of multiple sclerosis.
