Johnson & Johnson (J&J) has sought approval for TREMFYA (guselkumab) for paediatric conditions with the submission of two supplemental biologics licence applications (sBLA) to the US Food and Drug Administration (FDA).
The applications are intended for the use of the monoclonal antibody to treat paediatric patients aged six years and above with moderate-to-severe plaque psoriasis (PsO), and those five years and older with active juvenile psoriatic arthritis (jPsA).
The submission for treating paediatric plaque psoriasis is supported by results from the Phase III PROTOSTAR study in children. It is based on the bridging pharmacokinetic outcomes from the VOYAGE 1 and 2 studies in adults with the same condition.
For jPsA, the application utilised pharmacokinetic extrapolation analyses from adult psoriatic arthritis studies, DISCOVER 1 and 2, alongside data from the PROTOSTAR study.
Johnson & Johnson innovative medicine immunodermatology disease area leader and vice-president Liza O’Dowd stated: “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 and immune-mediated diseases.
“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.
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“At Johnson & Johnson, we are working to address this gap by investigating the efficacy and well-characterised safety profile of TREMFYA for paediatric patients.”
TREMFYA, which attaches to the p19 subunit of IL-23 and prevents its interaction with the receptor, is already approved for adult indications in the US, including moderate-to-severe plaque psoriasis, active psoriatic arthritis and ulcerative colitis.
It is also approved in Canada, Europe and Japan, among other countries, for treating the adult population with moderate-to-severe plaque psoriasis and active psoriatic arthritis.
In November 2024, the company sought approval from the US regulator for a new initiation regimen of the antibody in adults with ulcerative colitis.
