J&J's TREMFYA Receives FDA Approval For Moderately To Severely Active Ulcerative Colitis In Adults

(RTTNews) - Johnson & Johnson (JNJ) said 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 large intestine in which the lining of the colon becomes inflamed.

The company noted that the TREMFYA is the first and only approved fully-human, dual-acting monoclonal antibody that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23. IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of 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 received subsequent 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 seeking approval of TREMFYA for the treatment of adult patients with moderately to severely active Crohn's disease.

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