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FDA Clears Tremfya for Children 6 and Older With Plaque Psoriasis and Psoriatic Arthritis

The decision makes Tremfya the first IL-23 inhibitor cleared for pediatric use.

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J&J’s Tremfya approved by FDA for children with plaque psoriasis and psoriatic arthritis

Overview

  • Eligibility includes children aged six years and older who weigh at least 40 kg, with indications for moderate-to-severe plaque psoriasis requiring systemic therapy or phototherapy, and for active psoriatic arthritis.
  • In the phase 3 PROTOSTAR trial, 56% of patients on Tremfya achieved PASI 90 at week 16 versus 16% on placebo, with 66% reaching IGA 0/1 versus 16% and nearly 40% achieving IGA 0 versus 4%.
  • Approval of the pediatric psoriatic arthritis indication relied on pharmacokinetic extrapolation across the Tremfya program, including VOYAGE 1 and 2, DISCOVER 1 and 2, and PROTOSTAR.
  • The pediatric decision builds on prior U.S. approvals for adults with plaque psoriasis in 2017 and psoriatic arthritis in 2020.
  • Investigators and Johnson & Johnson highlighted a significant treatment gap for children with these immune-mediated diseases and framed the approval as providing a needed option with demonstrated efficacy.