Johnson & Johnson’s first oral interleukin‑23 (IL‑23) receptor antagonist, Icotyde (icotrokinra), received U.S. Food and Drug Administration approval on March 18, 2026, for the treatment of moderate‑to‑severe plaque psoriasis. The approval marks the first time an oral peptide has been cleared to block the IL‑23 pathway, a target that AbbVie’s injectable biologic Skyrizi (risankizumab) has long dominated.
The approval introduces a new competitive dynamic for AbbVie, whose Skyrizi has been a cornerstone of its post‑Humira growth strategy. AbbVie projects Skyrizi sales of $21.5 billion in 2026 and expects combined sales of Skyrizi and its other immunology drug Rinvoq to exceed $31 billion in 2026 and 2027. In 2025, the two drugs generated $25.9 billion in revenue, and analysts forecast a 23% year‑over‑year sales increase for Skyrizi in FY26E, indicating that the company still expects robust growth despite the new entrant.
The FDA approval was based on Phase 3 studies that demonstrated Icotyde’s efficacy in plaque psoriasis, although specific PASI or IGA endpoints were not disclosed in the fact‑check. The oral route offers a convenience advantage over Skyrizi’s periodic injections, a factor that could shift prescribing habits and potentially erode Skyrizi’s market share. Analysts at BNP Paribas, Citi, and Jefferies have noted the competitive threat, yet they also emphasize that Skyrizi’s strong efficacy and dosing schedule may help it maintain a leading position.
Management commentary underscores the significance of the approval. Jennifer Taubert, Executive Vice President and Worldwide Chairman of Innovative Medicine at Johnson & Johnson, said, "With the FDA approval of ICOTYDE, Johnson & Johnson is setting a new standard for the treatment of moderate‑to‑severe plaque psoriasis. We’re proud to bring this game‑changing innovation to the market, marking a transformative shift in plaque psoriasis management that empowers patients and clinicians to reach their treatment goals." Linda Stein Gold, MD, Director of Dermatology Clinical Research at Henry Ford Health, added, "ICOTYDE delivers something unique in psoriasis treatment – combining skin clearance with a favorable safety profile in a once‑daily pill, making it an easy addition to a patient’s routine."
John Reed, Executive Vice President of R&D for Innovative Medicine at J&J, noted, "The approval…represents a pivotal moment for people with plaque psoriasis. Icotyde is a fundamentally different treatment with the potential to redefine what physicians and patients can expect from psoriasis treatment."
The approval is a material regulatory event that will likely influence AbbVie’s competitive positioning in the IL‑23 therapeutic space and may prompt investors to reassess the company’s outlook in the psoriasis segment. The introduction of an oral competitor adds a new dimension to the market, but AbbVie’s projected sales growth for Skyrizi suggests that the company remains confident in its product’s market share and pricing power.
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