December 14, 2021 (Globe Newswire)
Prescription Drug User Fee Act (PDUFA) goal date of September 28, 2022
TG Therapeutics, Inc. (NASDAQ: TGTX) today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for ublituximab, the Company’s investigational glycoengineered anti-CD20 monoclonal antibody, as a treatment for patients with relapsing forms of multiple sclerosis (RMS). The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of September 28, 2022. The FDA also notified the Company that it is not currently planning to hold an advisory committee meeting to discuss this application.
Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics, stated, “We are excited to share that we have received formal communication from the FDA, and the BLA for ublituximab to treat relapsing forms of MS has been accepted and granted a standard review. This is a major milestone for us as it is our first U.S. marketing application for an autoimmune indication. We look forward to working with the FDA throughout this review process.”
The submission was based on the results of the ULTIMATE I & II trials, two identical Phase 3, randomized, global, multi-center, double-blinded, active-controlled trials evaluating ublituximab compared to teriflunomide in patients with RMS. The ULTIMATE I & II trials were conducted under a Special Protocol Assessment (SPA) agreement with the FDA.
ABOUT THE ULTIMATE I & II PHASE 3 TRIALS
ULTIMATE I and ULTIMATE II are two independent Phase 3, randomized, double-blinded, active-controlled, global, multi-center studies evaluating the efficacy and safety/tolerability of ublituximab (450mg dose administered by one-hour intravenous infusion every 6 months, following a Day 1 infusion of 150mg over four hours and a Day 15 infusion of 450mg over one hour) versus teriflunomide (14mg oral tablets taken once daily) in subjects with relapsing forms of Multiple Sclerosis (RMS). The ULTIMATE I & II trials enrolled a total of 1,094 patients with RMS across 10 countries. These trials were led by Lawrence Steinman, MD, Zimmermann Professor of Neurology & Neurological Sciences, and Pediatrics at Stanford University and were conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). As previously announced, both studies met their primary endpoint with ublituximab treatment demonstrating a statistically significant reduction in annualized relapse rate (ARR) compared to teriflunomide over a 96-week period (p<0.005 in each trial). Additional information on these clinical trials can be found at www.clinicaltrials.gov (NCT03277261; NCT03277248).
ABOUT UBLITUXIMAB
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