Johnson & Johnson Submits SBLA Seeking Approval Of TREMFYA In Ulcerative Colitis

(RTTNews) - Johnson & Johnson (JNJ) announced the submission of a supplemental Biologics License Application to the FDA seeking approval of a subcutaneous induction regimen of TREMFYA for the treatment of adults with moderately to severely active ulcerative colitis. The filing is supported by data from the Phase 3 ASTRO study of TREMFYA SC induction therapy in adults with UC.

TREMFYA received FDA approval in September 2024 for the treatment of adult patients with moderately to severely active UC and is currently administered via an IV induction regimen, followed by a SC maintenance regimen. An application seeking approval of TREMFYA for the treatment of adults with moderately to severely active Crohn's disease has been submitted in the U.S., and applications seeking approval for both CD and UC have been submitted in Europe.

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