J&J Seeks FDA Approval for Pediatric Tremfya Indications

Key Takeaways

• Johnson & Johnson (J&J) seeks FDA approval for Tremfya for the treatment of pediatric plaque psoriasis and juvenile psoriatic arthritis.
• The applications are supported by phase 3 data from the PROTOSTAR trial and adult bridging studies.
• The manufacturer said the approval could address a significant unmet need in pediatric dermatology.

Johnson & Johnson (J&J) has submitted supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) for Tremfya (guselkumab), seeking approval for pediatric indications.

Tremfya, the first approved monoclonal antibody IL-23 inhibitor that selectively binds to the p19 subunit of IL-23, targets a key pathway in autoimmune conditions, according to a press release from the manufacturer. The proposed uses include treatment for children aged six and older with moderate-to-severe plaque psoriasis and children aged five and older with active juvenile psoriatic arthritis (PsA). The submission is supported by findings from the phase 3 PROTOSTAR trial, supplemented by pharmacokinetic bridging data from adult studies (VOYAGE 1 and 2). Safety and efficacy data were derived from the PROTOSTAR study alongside adult PsA data from DISCOVER 1 and 2.

“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,” said Liza O’Dowd, MD, Vice President, Immunodermatology Disease Area Leader, J&J Innovative Medicine, in a press release. “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. We are working to address this gap by investigating the efficacy and well-characterized safety profile of Tremfya for pediatric patients.”

Source: J&J press release. December 2, 2024.