AbbVie said on March 30 that it remains confident in its drug Skyrizi’s efficacy following the recent approval of Johnson & Johnson and Protagonist Therapeutics’ oral peptide pill, Icotyde, by the Food and Drug Administration. The approval of Icotyde marks the first oral targeted therapy that blocks the IL-23 receptor and fully clears skin lesions in patients with plaque psoriasis.
The introduction of Icotyde places it in direct competition with AbbVie's Skyrizi, a biologic therapy targeting the same pathway. This development is significant as it could shift market dynamics within immunology treatments for moderate to severe plaque psoriasis.
Skyrizi was first approved in April 2019 and has since become a key product for AbbVie, generating $17.562 billion in revenue during 2025. It has also received approvals for other indications such as Crohn’s disease and ulcerative colitis. According to analysts at BMO Capital Markets, "While Icotyde is expected to take share, Skyrizi is likely to remain a value driver for AbbVie across I&I." The analysts added that "AbbVie does not underestimate competitive threats," but remains confident about Skyrizi's position.
Clinical trial data support this outlook: In Phase 3 studies UltIMMa-1 and UltIMMa-2, between 70% and 73% of patients treated with Skyrizi saw a 90% improvement from baseline on the Psoriasis Area and Severity Index (PASI) after sixteen weeks; between 36% and 49% achieved complete resolution of lesions (PASI-100). By comparison, results from Icotyde’s ICONIC-LEAD trial showed a placebo-adjusted PASI-90 rate of 46%, with about 27% reaching PASI-100 at sixteen weeks. However, cross-trial comparisons are inconclusive due to differences in study design.
BMO analysts also noted potential challenges related to adherence for daily oral medications like Icotyde: “Frequently dosed orals often bring adherence challenges with risk of reduced real-world efficacy,” they said. They suggested providers may prefer longer-lasting therapies such as Skyrizi, which requires subcutaneous administration every three months.
Despite these factors favoring Skyrizi, BMO stated that “we remain positive on the commercial opportunity presented by Icotyde as the first and only oral IL-23 on the market.” They projected peak sales for Icotyde could reach $3.2 billion by 2040 if it captures a substantial portion of an already large market.
Other competitors include Takeda's TYK2 inhibitor zasocitinib—which remains under Phase 3 development—and Amgen’s Otezla. Takeda plans to seek regulatory approval during its fiscal year starting April.
