FDA Approves Tremfya for pediatric Plaque Psoriasis and Active Psoriatic Arthritis
The FDA has approved Tremfya (guselkumab) for children aged 6 and above to treat plaque psoriasis and psoriatic arthritis, promising a new targeted therapy for young patients with these immune conditions.
The U.S. Food and Drug Administration (FDA) has approved Johnson & Johnson's Tremfya (guselkumab) for the treatment of plaque psoriasis and active psoriatic arthritis in children aged 6 years and older. This marks a significant advancement in pediatric dermatology and rheumatology, providing a new targeted therapy for young patients who have moderate to severe forms of these immune-mediated conditions. The approval was based on findings from the Phase III PROTOSTAR clinical trial, which demonstrated the medication's efficacy in achieving notable skin clearance and disease control.
In the study, more than half of the pediatric participants treated with Tremfya attained at least 90% improvement in their psoriasis severity (PASI 90) by week 16, compared to only 16% in the placebo group. Additionally, two-thirds of the children achieved high levels of skin clearance (IGA score of 0 or 1), and nearly 40% achieved complete clearance (IGA 0). These results highlight Tremfya's effectiveness in managing symptoms and improving quality of life for young patients.
According to Dr. Vimal Hasmukh Prajapati from the University of Calgary, "Despite progress in pediatric psoriasis treatment, there remains a gap in safe and effective therapies for children with these challenging diseases. The approval of Tremfya offers clinicians and families a trusted option with proven safety and efficacy." The new indication broadens the scope of interleukin-23 inhibitors, which now include pediatric populations, expanding treatment possibilities for children suffering from these serious conditions.
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