Improving DxMultiomics, Powered by Your Choices

We're building DxMultiomics to be The Central Nexus of Biotech Intelligence. To ensure a seamless experience and continuous improvement, we utilize website analytics. These tools help us monitor site performance, understand how users navigate the platform, and identify opportunities to make your research journey more efficient. We handle this data with the utmost respect for your privacy, and you can choose what works best for you.

U.S. FDA Approves TREMFYA: First and Only IL-23 Inhibitor for Pediatric Plaque Psoriasis and Active Psoriatic Arthritis
_↗ jnj.com
News Image

The U.S. Food and Drug Administration (FDA) has approved TREMFYA® (guselkumab) for two significant pediatric indications, as announced by Johnson & Johnson: the treatment of children six years and older who weigh at least 40 kg with moderate to severe plaque psoriasis (PsO) and those with active psoriatic arthritis (PsA). This landmark decision makes TREMFYA the first and only IL-23 inhibitor approved for these pediatric conditions, building on its existing approvals for adults with PsO and PsA. This new therapeutic option is crucial for the approximately 20,000 children under 10 diagnosed with plaque PsO annually and 14,000 children impacted by PsA, which are debilitating, chronic, immune-mediated diseases that severely affect a child's physical and emotional well-being.: the treatment of children six years and older who weigh at least 40 kg with moderate to severe plaque psoriasis (PsO) and those with active psoriatic arthritis (PsA). This landmark decision makes TREMFYA the first and only IL-23 inhibitor approved for these pediatric conditions, building on its existing approvals for adults with PsO and PsA. This new therapeutic option is crucial for the approximately 20,000 children under 10 diagnosed with plaque PsO annually and 14,000 children impacted by PsA, which are debilitating, chronic, immune-mediated diseases that severely affect a child's physical and emotional well-being.

The approval for pediatric plaque PsO was largely based on the results from the Phase 3 PROTOSTAR study, which demonstrated significant efficacy. In this trial, approximately 56% of pediatric patients receiving TREMFYA achieved PASI 90 (90% skin clearance) at Week 16, compared to only 16% of patients on placebo. Furthermore, 66% achieved high levels of skin clearance (IGA score of 0 or 1), compared to 16% on placebo. The approval for active PsA was supported by pharmacokinetic extrapolation analyses and evidence from the adult PsO and PsA studies, as well as the pediatric PsO data. Experts and patient advocates alike have welcomed the approval, highlighting the persistent gap in available therapies and the potential for TREMFYA, with its established safety profile and demonstrated efficacy, to significantly improve the signs and symptoms in children's critical developmental years. TREMFYA, a fully-human, dual-acting monoclonal antibody developed by Johnson & Johnson, works by blocking IL-23, a key cytokine known to drive these immune-mediated diseases. For these pediatric indications, the recommended dosage is 100 mg administered as a subcutaneous injection at Week 0, Week 4, and then every 8 weeks thereafter. This milestone underscores Johnson & Johnson’s commitment to advancing treatment for chronic immune-mediated diseases across all age groups.

Log In
Sign Up