J&J’s TREMFYA receives FDA approval for moderately to severely active ulcerative colitis in adults

NEW BRUNSWICK (dpa-AFX) – Johnson & Johnson (JNJ) reported that the U.S. Food and Drug Administration has approved TREMFYA (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC), a chronic disease of the colon in which the lining of the large intestine becomes inflamed.

The company noted that TREMFYA is the first and only approved fully human, dual-acting monoclonal antibody that blocks IL-23 and simultaneously binds to CD64, a receptor on cells that produce IL-23. IL-23 is a cytokine secreted by activated monocytes/macrophages and dendritic cells that is known to drive immune-mediated diseases, including UC.

The FDA approval marks the third indication approved for TREMFYA. TREMFYA first received approval in the U.S. in July 2017 for the treatment of adult patients with moderate to severe plaque psoriasis and subsequently received approval for adults with active psoriatic arthritis in July 2020.

In June 2024, Johnson & Johnson submitted a supplemental Biologics License Application (sBLA) to the FDA requesting approval of TREMFYA for the treatment of adult patients with moderately to severely active Crohn’s disease.

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