On 2 December 2024, Johnson & Johnson announced its submission of two supplemental Biologics License Applications (sBLAs) to FDA for approval of Tremfya® (guselkumab) for the treatment of children 6 years of age and older with moderate-to-severe plaque psoriasis (PsO) and children 5 years of age and older with active juvenile psoriatic arthritis (jPsA). These submissions come more than seven years after Tremfya® was approved for treating PsO in adults in the US, where it is also approved for PsA and ulcerative colitis in adults.
Tremfya® is approved in Europe and other countries for plaque psoriasis and active psoriatic arthritis.