TREMFYA® (guselkumab) has been approved by the U.S. Food and Drug Administration (FDA) to treat children with active psoriatic arthritis and moderate to severe plaque psoriasis. Since TREMFYA® is the first and only IL-23 inhibitor authorized for these illnesses in children, this is a major milestone.
Johnson & Johnson was given the approval, which permits TREMFYA® to be used in children six years of age and older who weigh at least 40 kg. The drug is recommended for individuals with pediatric plaque psoriasis who are suitable for phototherapy or systemic therapy.
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Positive findings from the Phase 3 PROTOSTAR research, which showed that TREMFYA® was effective in treating pediatric patients with plaque psoriasis, served as the foundation for the FDA’s decision. Compared to participants who got a placebo, a noticeably greater proportion of patients who received the treatment experienced clear or almost clear skin.
Data from studies on psoriasis in adults and children supported the approval of active psoriatic arthritis in children. Psoriatic arthritis is a long-term inflammatory condition that impacts the skin and joints.
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For the thousands of youngsters afflicted by these crippling illnesses, this new indication for TREMFYA® offers a much-needed therapeutic option. Each year, 14,000 children are diagnosed with psoriatic arthritis and an estimated 20,000 children under the age of ten are diagnosed with plaque psoriasis.
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