Healthcare products company Johnson & Johnson (J&J) (NYSE:JNJ) announced on Friday that it has submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) seeking approval for a subcutaneous induction regimen of TREMFYA (guselkumab) for adults with moderately to severely active ulcerative colitis (UC).

This submission, if approved, would make TREMFYA the only IL-23 inhibitor to offer both subcutaneous and intravenous induction options for UC.

The sBLA is supported by data from the Phase 3 ASTRO study, which met its primary endpoint of clinical remission at Week 12. The safety profile of TREMFYA was consistent with previous studies.