JnJ seeks USFDA approval for subcutaneous induction regimen of Tremfya in ulcerative colitis
Spring House: Johnson & Johnson has announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of a subcutaneous (SC) induction regimen of TREMFYA (guselkumab) for the treatment of adults with moderately to severely active UC. The filing is supported by data from the Phase 3 ASTRO study of TREMFYA SC induction therapy in adults with UC and builds upon the recent U.S. approval of TREMFYA in this indication.
The Phase 3 ASTRO study met its primary endpoint, achieving a statistically significant and clinically meaningful results or clinical remission at Week 12 with a 400 mg SC induction dose of TREMFYA administered at Weeks 0, 4, and 8. All secondary endpoints, including endoscopic improvement and histologic-endoscopic mucosal improvement (HEMI), were also met. Safety data from ASTRO were consistent with the safety findings from the QUASAR program. Results from the ASTRO study are planned for presentation at upcoming medical meetings.
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