J&J(JNJ) Prnewswire·2024-12-02 13:00Core Insights - Johnson & Johnson has submitted two supplemental Biologics License Applications (sBLAs) to the FDA for TREMFYA® (guselkumab) to treat children aged 6 and older with moderate-to-severe plaque psoriasis and children aged 5 and older with active juvenile psoriatic arthritis [1][2] - The submissions are based on data from various Phase 3 studies, including the PROTOSTAR study for pediatric plaque psoriasis and extrapolated data from adult studies for juvenile psoriatic arthritis [1][4][5] - The company emphasizes its commitment to addressing the treatment gap for children and adolescents suffering from these conditions, highlighting the debilitating impact of visible skin diseases on this demographic [1][3] Company Overview - TREMFYA® is the first approved monoclonal antibody that selectively targets the p19 subunit of IL-23, a key driver of immune-mediated diseases like plaque psoriasis and psoriatic arthritis [1][6] - Johnson & Johnson maintains exclusive worldwide marketing rights for TREMFYA®, which is already approved for adult patients in multiple countries [6][9] Clinical Study Details - The PROTOSTAR study is a Phase 3 trial evaluating the efficacy, safety, and pharmacokinetics of TREMFYA® in pediatric patients with chronic plaque psoriasis, with co-primary endpoints including Investigator's Global Assessment (IGA) and PASI 75 at Week 16 [4] - The VOYAGE studies assessed TREMFYA® in adults with moderate to severe plaque psoriasis, focusing on achieving clear or almost clear skin and significant improvement in psoriasis severity [4][5] - The DISCOVER studies evaluated TREMFYA® in adults with active psoriatic arthritis, measuring the response rate at Week 24 [5]