By Colin Kellaher
TG Therapeutics Inc. on Thursday said it filed for U.S. Food and Drug Administration approval of ublituximab as a treatment for patients with relapsing forms of multiple sclerosis.
The New York biopharmaceutical company said the application is based on a pair of Phase 3 studies in which ublituximab treatment showed a statistically significant reduction in annualized relapse rate compared to teriflunomide over 96 weeks.
TG Therapeutics said the filing, its first marketing application for an autoimmune indication, rounds out its near-term U.S. regulatory submissions.
The company in May said the FDA had accepted its application for ublituximab in combination with Ukoniq for patients with chronic lymphocytic leukemia and small lymphocytic lymphoma.
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