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Us Fda Approves J&j's Oral Psoriasis Pill

FDA approved Icotyde, the first oral IL-23-targeted pill for moderate-to-severe plaque psoriasis, showing 65% of patients achieved 90% skin clearance in trials.

  • On Wednesday, the U.S. Food and Drug Administration approved Icotyde, Johnson & Johnson's oral pill for moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years and older who weigh at least 88 pounds.
  • Developed as icotrokinra, Icotyde was designed to mirror injectables like Skyrizi and Tremfya without needles, addressing patients who often avoid injections after topicals; Johnson & Johnson licensed it from Protagonist Therapeutics in 2017 in a deal worth up to $1 billion.
  • ICONIC-ADVANCE 1 and 2 and ICONIC-LEAD showed about two-thirds of treated patients achieved at least 90% skin clearance versus about 40%, with 15-20% IGA differences, Linda Stein Gold said.
  • J&J projects more than $5 billion in peak sales for Icotyde, triggering a $50 million milestone payment to Protagonist, while shares of J&J slid 0.25% Wednesday and AbbVie fell over 4%.
  • Johnson & Johnson is already testing Icotyde in psoriatic arthritis, ulcerative colitis and Crohn's disease, with Jennifer Taubert calling it "revolutionary" for patients and clinicians.
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STAT broke the news in Boston, United States on Wednesday, March 18, 2026.
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