SPRING HOUSE, PA — Johnson & Johnson has submitted two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA), aiming to expand the use of TREMFYA® (guselkumab) for pediatric patients. The applications seek approval to treat children aged 6 and older with moderate-to-severe plaque psoriasis (PsO) and children aged 5 and older with active juvenile psoriatic arthritis (jPsA).
The application for plaque psoriasis is based on data from the Phase 3 PROTOSTAR study in pediatric patients and additional pharmacokinetic (PK) data from adult studies, VOYAGE 1 and 2. For jPsA, the request is supported by PK extrapolation from the DISCOVER 1 and 2 adult studies, alongside efficacy and safety data from the PROTOSTAR study.
Liza O’Dowd, M.D., Vice President, Immunodermatology Disease Area Leader at Johnson & Johnson Innovative Medicine, emphasized the importance of this step, stating, “This milestone underscores our commitment to transform the standard of care for patients of all ages.” Addressing the challenges children face with these conditions, O’Dowd highlighted the need for targeted therapies to help improve their quality of life.
TREMFYA®, a monoclonal antibody that selectively inhibits the IL-23 pathway, is already approved for adults with plaque psoriasis and psoriatic arthritis. The expansion into pediatric use could fill a significant treatment gap and provide new options for managing immune-mediated diseases in younger patients.
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