J&J Seeks FDA Approval for TREMFYA in Pediatric Conditions

Johnson & Johnson (J&J) is seeking approval from the US Food and Drug Administration (FDA) for the use of TREMFYA (guselkumab) to treat certain pediatric conditions. The company has submitted two supplemental biologics license applications (sBLA) for this purpose. TREMFYA is a monoclonal antibody proposed for treating moderate-to-severe plaque psoriasis in children aged six years and above, as well as active juvenile psoriatic arthritis in children aged five years and older.

The submission for pediatric plaque psoriasis is backed by data from the Phase III PROTOSTAR study, which involved children. This submission also includes bridging pharmacokinetic outcomes derived from the VOYAGE 1 and 2 studies, which focused on adults with the same condition. For juvenile psoriatic arthritis, the application integrates pharmacokinetic extrapolation analyses from adult studies, DISCOVER 1 and 2, in addition to data from the PROTOSTAR study.

Liza O’Dowd, Johnson & Johnson's vice-president and leader in innovative medicine immunodermatology disease area, remarked that this achievement highlights the company's dedication to revolutionizing the standard of care across all age groups. O'Dowd emphasized that there is a significant gap in treating children and adolescents with these skin and joint conditions, which can severely impact their physical appearance and functionality. Johnson & Johnson aims to bridge this gap by examining the efficacy and safety profile of TREMFYA in pediatric patients.

TREMFYA functions by targeting the p19 subunit of IL-23 and inhibiting its interaction with the receptor. It is already approved in the United States for adult use in treating moderate-to-severe plaque psoriasis, active psoriatic arthritis, and ulcerative colitis. Beyond the US, TREMFYA is also approved for treating moderate-to-severe plaque psoriasis and active psoriatic arthritis in adults in Canada, Europe, Japan, and other countries.

In addition to these approvals, in November 2024, Johnson & Johnson applied for FDA approval for a new initiation regimen of TREMFYA for adults with ulcerative colitis.