FX.co ★ Johnson & Johnson Submits SBLA Seeking Approval Of TREMFYA In Ulcerative Colitis

Johnson & Johnson (JNJ) has announced that it has submitted a supplemental Biologics License Application to the U.S. Food and Drug Administration (FDA). The goal is to obtain approval for a subcutaneous induction regimen of TREMFYA, intended for adult patients suffering from moderately to severely active ulcerative colitis. This submission is backed by results from the Phase 3 ASTRO study evaluating TREMFYA's subcutaneous induction therapy in adult patients with this condition.

TREMFYA has previously secured FDA approval, as of September 2024, for treating adult patients with moderately to severely active ulcerative colitis. The treatment is currently delivered through an intravenous induction regimen, followed by subcutaneous maintenance. Moreover, an application for the approval of TREMFYA for adults with moderately to severely active Crohn's disease has been filed in the U.S., and similar applications for Crohn's disease and ulcerative colitis are under consideration in Europe.