Johnson & Johnson submits sBLA to FDA for TREMFYA (guselkumab) in ulcerative colitis treatment, supported by Phase 3 QUASAR data.
Johnson & Johnson has submitted a sBLA to the FDA for TREMFYA (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC). The application is supported by Phase 3 QUASAR program data showing improved clinical remission rates at Week 44 compared to placebo. If approved, TREMFYA would be the first IL-23 inhibitor for UC, with safety results consistent with its known safety profile in approved indications.
March 11, 2024
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