Johnson & Johnson (NYSE: JNJ) has announced that the U.S. Food and Drug Administration (FDA) has approved TREMFYA® (guselkumab) for the treatment of children aged six and older, weighing at least 40 kg, with moderate to severe plaque psoriasis (PsO) or active psoriatic arthritis (PsA). This approval makes TREMFYA® the first and only IL-23 inhibitor available for these pediatric conditions, expanding its use beyond its initial FDA approvals for adults with moderate to severe plaque PsO in 2017 and active PsA in 2020.
This milestone offers new hope for the approximately 20,000 children under 10 diagnosed annually with plaque PsO and the 14,000 children affected by PsA. PsO, a chronic immune-mediated disease, causes inflamed, scaly plaques that can be itchy, painful, and emotionally distressing, while PsA is characterized by joint inflammation, swelling, and PsO, potentially impacting a child’s physical and emotional well-being.
Dr. Vimal Hasmukh Prajapati, Clinical Associate Professor at the University of Calgary and a study investigator, emphasized the significance of this approval: “Despite advancements in pediatric treatments, there remains a gap in therapies for these debilitating diseases. TREMFYA® provides a proven, effective option that can significantly improve the quality of life for children and their families.”
The FDA’s decision was based on data from the Phase 3 PROTOSTAR study, which evaluated TREMFYA® in pediatric patients with moderate to severe plaque PsO. Results showed that at Week 16, 56% of patients receiving TREMFYA® achieved a 90% improvement in the Psoriasis Area Severity Index (PASI 90), compared to 16% of those on placebo. Additionally, 66% of patients achieved clear or almost clear skin (IGA score of 0/1) versus 16% on placebo. Nearly 40% of patients experienced complete skin clearance (IGA 0), compared to just 4% on placebo.
For pediatric PsA, approval was supported by pharmacokinetic extrapolation analyses from adult studies, including VOYAGE 1 and 2, DISCOVER 1 and 2, and PROTOSTAR. These analyses confirmed the efficacy and safety of TREMFYA® in children, aligning with findings from adult populations.
TREMFYA® is administered via subcutaneous injection at Week 0, Week 4, and every eight weeks thereafter. The recommended dosage for pediatric patients is 100 mg, delivered using a 1 mL prefilled syringe. This treatment offers a much-needed option for children who may otherwise face significant physical and emotional challenges due to their conditions.
Leah M. Howard, JD, President and CEO of the National Psoriasis Foundation, highlighted the impact of these diseases: “Psoriasis and psoriatic arthritis can leave children feeling isolated and unable to participate in everyday activities. This approval provides hope for relief from the pain and emotional burden these conditions bring.”
About TREMFYA®
Developed by Johnson & Johnson, TREMFYA® is the first fully-human, dual-acting monoclonal antibody designed to block IL-23 and bind to CD64, a receptor on cells that produce IL-23. This dual action targets inflammation at its cellular source, addressing the root cause of immune-mediated diseases like PsO and PsA. While findings for dual-acting mechanisms are based on in vitro studies, the clinical significance of this feature is still being explored.
TREMFYA® is also approved for adults with moderately to severely active ulcerative colitis and Crohn’s disease, as well as for pediatric and adult patients with moderate to severe plaque PsO and active PsA. It is available in multiple countries, including Europe, Canada, and Japan.
This approval underscores Johnson & Johnson’s commitment to advancing treatments for chronic immune-mediated diseases. Brandee Pappalardo, PhD, MPH, Vice President of Medical Affairs, Dermatology & Rheumatology at Johnson & Johnson, stated, “Every child deserves to feel comfortable in their own skin and live without the limitations of joint pain and swelling. This approval is a significant step forward for children and their families.”
For more information about TREMFYA®, visit www.tremfya.com.
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