IN BRIEF: J&J seeks approval for ulcerative colitis drug, Tremfya

22nd November 2024 21:22

Johnson & Johnson - New Brunswick, New Jersey-based pharmaceutical company - Seeks US Food & Drug Administration approval for subcutaneous induction regimen of Tremfya in ulcerative colitis, a first for an IL-23 inhibitor. Application for a supplemental Biologics License Application is supported by data from the phase 3 Astro study. The study met its primary endpoint, achieving a statistically significant and clinically meaningful results for clinical remission at week 12. Safety data from Astro is consistent with the safety findings from the Quasar program.

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By Jeremy Cutler, Alliance News reporter

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