News/Regulation/Sep 21, 2026

European Commission approves ICOTYDE for moderate-to-severe plaque psoriasis

The European Commission granted marketing authorisation to ICOTYDE (icotrokinra), an oral IL-23 receptor blocker, for adults and adolescents aged 12 and older weighing at least 40 kg who are candidates for systemic therapy. The EU decision extends the product's first-line psoriasis launch beyond the United States, where it was approved in March 2026. Head-to-head Phase 3 studies against deucravacitinib showed about 70% of patients reached clear or almost clear skin at week 16.

  • EU approval for moderate-to-severe plaque psoriasis in patients 12 and older (at least 40 kg)
  • About 70% IGA 0/1 and 55% PASI 90 at week 16 in head-to-head studies vs deucravacitinib
  • Safety rates within 1.1% of placebo through week 16
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266.86270.85274.83European Commission approves ICOTYDE for moderate-to-severe plaque psoriasis1Sep 17Sep 19Sep 21Sep 23Sep 25
Source
Johnson & Johnson press release
Sep 21, 2026
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