HORSHAM, PA — Johnson & Johnson (NYSE: JNJ) announced that the U.S. Food and Drug Administration has approved TREMFYA® (guselkumab) for children six years and older weighing at least 40 kilograms with moderate to severe plaque psoriasis or active psoriatic arthritis. The decision marks the first approval of an IL-23 inhibitor for pediatric patients in these indications.
The expanded use builds on TREMFYA’s earlier FDA approvals in adults for moderate to severe plaque psoriasis in 2017 and active psoriatic arthritis in 2020. Johnson & Johnson estimates the approvals could impact approximately 20,000 children diagnosed annually with plaque psoriasis and 14,000 with psoriatic arthritis in the U.S.
Clinical data supporting the approval included the Phase 3 PROTOSTAR study, where 56% of pediatric patients achieved Psoriasis Area Severity Index (PASI) 90 at week 16 compared to 16% on placebo. In addition, 66% of treated patients reached high levels of skin clearance, and nearly 40% achieved complete clearance, significantly outperforming placebo. For psoriatic arthritis, efficacy was supported by pharmacokinetic extrapolation from adult and pediatric trial data.
“Despite advancements in the treatment of pediatric plaque psoriasis and active psoriatic arthritis, there continues to be a significant gap in available therapies,” said Dr. Vimal Hasmukh Prajapati, study investigator and Clinical Associate Professor at the University of Calgary. “The approval of TREMFYA offers physicians, parents and care partners an established treatment option with proven safety and demonstrated efficacy.”
Johnson & Johnson highlighted that TREMFYA is the only fully human, dual-acting monoclonal antibody approved to block IL-23 while binding to CD64, a receptor on IL-23-producing cells. For children meeting the criteria, the therapy will be administered via subcutaneous injection at week 0, week 4, and every 8 weeks thereafter, at a 100 mg dose.
“Every child deserves to feel comfortable in their own skin and to be active without the limitations of joint pain, stiffness and swelling,” said Brandee Pappalardo, PhD, MPH, Vice President of Medical Affairs, Dermatology & Rheumatology at Johnson & Johnson Innovative Medicine. “The approval of the first and only pediatric indications for an IL-23 inhibitor marks an important step forward.”
TREMFYA is already approved for adults with ulcerative colitis and Crohn’s disease. Johnson & Johnson has also filed to update its label to reflect evidence showing inhibition of joint structural damage in adult psoriatic arthritis patients.
The latest approval reinforces the company’s continued focus on therapies addressing chronic immune-mediated diseases, extending established treatment options to a younger patient population facing significant unmet medical needs.
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