On 20 March 2025, Johnson & Johnson (J&J) announced that the US FDA has approved Tremfya® (guselkumab) for adult patients with moderately to severely active Crohn’s disease. According to J&J, Tremfya® is the first and only IL-23 inhibitor offering both subcutaneous and intravenous induction options.
Tremfya® is approved in the US for a number of indications, including for the treatment of adults with moderately to severely active ulcerative colitis (September 2024) and adults with plaque psoriasis (PsO) (July 2017).
In December 2024, J&J announced its submission to the FDA of two supplemental Biologics Licence Applications (sBLAs) for approval of Tremfya® for the treatment of children 6 years of age and older with moderate-to-severe PsO and children 5 years of age and older with active juvenile psoriatic arthritis (jPsA).