> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# J&J Seeks Tremfya Approval for Pediatric Uses
- URL: https://www.fdaweb.com/j-j-seeks-tremfya-approval-for-pediatric-uses/
- Published: 2024-12-02T12:00:00.000Z
- Updated: 2026-09-14T14:48:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158283

Johnson & Johnson has submitted two supplemental BLAs for Tremfya (guselkumab) for treating children six years and older with moderate-to-severe plaque psoriasis (PsO) and children five years of age and older with active juvenile psoriatic arthritis (jPsA). Tremfya is currently approved for treating adults with moderate to severe plaque psoriasis, active psoriatic arthritis, and ulcerative colitis.

“The PsO submission is based on data from the Phase 3 PROTOSTAR study in pediatric patients with moderate to severe plaque PsO and bridging pharmacokinetic (PK) data from the Phase 3 VOYAGE 1 and 2 studies in adult patients with moderate to severe plaque PsO,” the company says. “The jPsA submission is based on PK extrapolation analyses from adult PsA studies (DISCOVER 1 and 2) and Tremfya efficacy and safety data from the PROTOSTAR study.”

Tremfya is described as the first approved monoclonal antibody that selectively binds to the p19 subunit of interleukin (IL)-23 and inhibits its interaction with the IL-23 receptor. J&J says IL-23 is an important driver of immune-mediated diseases such as plaque PsO and PsA.