Johnson & Johnson (JNJ.US) submits regulatory application to FDA for antibody therapy for moderate to severe active ulcerative colitis

Johnson & Johnson (JNJ.US) announced that it has submitted a supplemental Biologics License Application (sBLA) to the US FDA seeking approval of its anti-IL-23 antibody Tremfya (guselkumab) as a subcutaneous (SC) induction regimen for the treatment of adults with moderate to severe active ulcerative colitis (UC).