Johnson & Johnson Seeks FDA Approval for Tremfya to Treat Pediatric Psoriasis and Arthritis
核心洞察
Johnson & Johnson has submitted sBLAs to the FDA for Tremfya (guselkumab) to treat moderate-to-severe plaque psoriasis (搜索) in children aged 6 and older.
The submission also seeks approval for Tremfya to treat active juvenile psoriatic arthritis (搜索) in children aged 5 and older.
The sBLAs are based on data from the Phase 3 PROTOSTAR study and pharmacokinetic data from adult studies VOYAGE 1 and 2, and DISCOVER 1 and 2.
Johnson & Johnson has submitted supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) seeking approval for Tremfya (guselkumab) to treat moderate-to-severe plaque psoriasis (搜索) (PsO) in children aged 6 years and older, and active juvenile psoriatic arthritis (搜索) (jPsA) in children aged 5 years and older. This action aims to address a critical gap in treatment options for young patients suffering from these conditions.
The sBLA for plaque psoriasis (搜索) is supported by data from the Phase 3 PROTOSTAR study in pediatric patients, along with bridging pharmacokinetic (PK) data from the Phase 3 VOYAGE 1 and 2 studies in adults with moderate-to-severe plaque PsO. The jPsA submission is based on PK extrapolation analyses from the adult psoriatic arthritis (搜索) studies DISCOVER 1 and 2, combined with efficacy and safety data from the PROTOSTAR study.
Addressing Unmet Needs in Pediatric Psoriatic Disease
"This milestone underscores our commitment to transform the standard of care for patients of all ages and builds on our expertise and legacy in IL-23 (搜索) and immune-mediated diseases," said Liza O'Dowd, M.D., Vice President, Immunodermatology Disease Area Leader, Johnson & Johnson Innovative Medicine. "There is a critical gap in the treatment of children and adolescents with these skin and joint conditions, where debilitating symptoms can present challenges related to physical appearance and ability to function. At Johnson & Johnson, we are working to address this gap by investigating the efficacy and well-characterized safety profile of TREMFYA for pediatric patients."
About Tremfya (Guselkumab)
Tremfya is a fully human monoclonal antibody that selectively binds to the p19 subunit of IL-23 (搜索), inhibiting its interaction with the IL-23 receptor. IL-23 is a key cytokine involved in the pathogenesis of immune-mediated diseases, including plaque psoriasis (搜索) and psoriatic arthritis (搜索). Tremfya is already approved for the treatment of moderate-to-severe plaque psoriasis, active psoriatic arthritis, and ulcerative colitis (搜索) in adult patients.
Clinical Trial Data Supporting the sBLAs
The PROTOSTAR study is a Phase 3, multicenter, randomized, placebo- and active comparator-controlled study evaluating the efficacy, safety, and pharmacokinetics of subcutaneously administered Tremfya for the treatment of chronic plaque psoriasis (搜索) in pediatric patients aged six years and older. Co-primary endpoints of the study were Investigator's Global Assessment (IGA) 0/1 and PASI 75 at Week 16.
The VOYAGE 1 and 2 studies were Phase 3 randomized, double-blind, placebo- and active comparator-controlled studies designed to evaluate the efficacy and safety of Tremfya compared with placebo and adalimumab in adults with moderate to severe plaque PsO. The co-primary endpoints of the studies were the proportions of patients receiving Tremfya versus patients receiving placebo achieving Investigator's Global Assessment (IGA) 0/1 (clear/almost clear skin) and PASI 90 at week 16.
The DISCOVER-1 was a Phase 3, multicenter, randomized, double-blind study evaluating the efficacy and safety of Tremfya administered by subcutaneous injection in participants with active PsA, including those previously treated with one to two tumor necrosis factor inhibitors (TNFi). The primary endpoint was response of ACR20 at week 24. DISCOVER-2 was a Phase 3, multicenter, randomized, double-blind study evaluating the efficacy and safety of Tremfya administered by subcutaneous injection in biologic-naïve patients with active PsA. The primary endpoint was response of ACR20 at week 24.
Psoriasis and Juvenile Psoriatic Arthritis in Children
Plaque psoriasis (搜索) is an immune-mediated disease resulting in the overproduction of skin cells, causing inflamed, scaly plaques that may be itchy or painful. Almost one-third of psoriasis cases begin in childhood, with approximately 20,000 children under 10 diagnosed each year. Visible skin disease can be highly stressful for children and adolescents and can have a long-term impact on those affected.
Juvenile psoriatic arthritis (搜索) is a form of juvenile idiopathic arthritis characterized by chronic joint inflammation, swelling, and psoriasis. It accounts for approximately 5% of the juvenile idiopathic arthritis population. In many cases, the skin manifestations start before the arthritis.