FDA Approves TREMFYA® for Pediatric Psoriasis and Psoriatic Arthritis

In a significant advancement for pediatric care, the U.S. Food and Drug Administration (FDA) has approved TREMFYA (guselkumab) for the treatment of children aged 6 years and older with moderate to severe plaque psoriasis (PsO) or active psoriatic arthritis (PsA). This marks a milestone as TREMFYA® is the first and only IL-23 inhibitor authorized for these conditions in pediatric patients.

TREMFYA® is approved for pediatric patients weighing at least 40 kg who are candidates for systemic therapy or phototherapy. This approval provides new therapeutic options for the approximately 20,000 children under 10 who are diagnosed with plaque PsO annually and the 14,000 affected by PsA.

The approval is supported by the Phase 3 PROTOSTAR study, which demonstrated that 56% of participants receiving TREMFYA achieved a Psoriasis Area Severity Index (PASI) 90 score, compared to 16% in the placebo group. Additionally, 66% of patients receiving TREMFYA® reached high skin clearance levels (Investigator's Global Assessment score of 0/1) at Week 16.

Dr. Vimal Hasmukh Prajapati, a clinical associate professor, emphasized the need for more treatment options for these debilitating diseases, noting the positive impact of TREMFYA® on children's physical and emotional well-being.

For pediatric plaque PsO and PsA, TREMFYA® is dosed at 100 mg via subcutaneous injection at Week 0, Week 4, and every eight weeks thereafter.

In conclusion, the introduction of TREMFYA® offers hope to many families affected by plaque psoriasis and psoriatic arthritis, providing a proven treatment option designed to improve the quality of life for young patients. Johnson & Johnson remains dedicated to ongoing research to validate the long-term efficacy and safety of TREMFYA®.

For more information, please see the official press release HERE.

Elevate-Derm Alliance Editorial Committee