TYK2 inhibitor( Bristol Myers Squibb)

iStock, designer491 AbbVie’s Skyrizi appears to have stronger efficacy than Johnson & Johnson’s newly approved pill Icotyde, as well as a less frequent dosing schedule that patients could prefer, according to analysts at BMO Capital Markets. AbbVie is ready to face off against the newest kid on the immunology block: Johnson & Johnson and Protagonist Therapeutics’ peptide pill Icotyde. The FDA gave the greenlight to Icotyde earlier this month, marking the first oral targeted therapy that blocks the IL-23 receptor and completely clears the skin of patients with plaque psoriasis. This puts the drug’s sponsors in direct competition with immuno stalwart AbbVie, which owns Skyrizi, a biologic therapy that also targets the IL-23 cascade. First approved in April 2019 for moderate to severe plaque psoriasis, Skyrizi has since become a cornerstone of AbbVie’s portfolio, growing into a $17.562 billion franchise in 2025 to help the pharma gracefully ride out the patent cliff of its mega-blockbuster Humira. The therapeutic antibody has also picked up several other indications, including Crohn’s disease and ulcerative colitis. Skyrizi was the industry’s fifth top-selling drug last year. Earnings Keytruda Hangs On to Best Seller Crown as GLP-1s Gain Ground Merck’s Keytruda will soon lose exclusivity, just as weight-loss giants Eli Lilly and Novo Nordisk press in with their blockbuster GLP-1s. March 4, 2026 · 9 min read · Tristan Manalac Read more “While Icotyde is expected to take share, Skyrizi is likely to remain a value driver for AbbVie across I&I,” analysts at BMO Capital Markets wrote in a note to investors on Friday afternoon after catching up with AbbVie management to clear up competitive concerns following Icotyde’s approval. “AbbVie does not underestimate competitive threats,” the note continued, “but is confident in the strength of Skyrizi.” Key to AbbVie’s confidence is the drug’s superior efficacy. At 16 weeks in the Phase 3 UltIMMa-1 and UltIMMa-2 studies, 70% to 73% of patients treated with Skyrizi saw a 90% improvement from baseline in Psoriasis Area and Severity Index (PASI) scores, a key tool used to assess disease severity, as compared with placebo. At the same follow-up, 36% to 49% saw a 100% PASI improvement, BMO added, meaning the complete resolution of lesions. In contrast, Icotyde achieved a 46% placebo-adjusted PASI-90 at 16 weeks in the late-stage ICONIC-LEAD trial, while roughly 27% achieved PASI-100, BMO reported. (In the absence of a direct head-to-head study, cross-trial comparisons are inconclusive.) Aside from an efficacy edge, Icotyde’s oral availability and daily dosing schedule could also work against it, the analysts continued. “Frequently dosed orals often bring adherence challenges with risk of reduced real-world efficacy,” they explained, noting that skipped doses could lower the drug’s therapeutic benefit. In turn, “providers and patients may favor longer-acting/durable therapies like Skyrizi,” which is administered subcutaneously every three months. Approvals J&J Wins FDA Nod for First Targeted Oral Anti-IL-23 Therapy for Plaque Psoriasis Icotyde, co-developed by Johnson & Johnson and Protagonist Therapeutics, is backed by data from the Phase 3 ICONIC program, which, among other advantages, showed significant superiority over Bristol Myers Squibb’s Sotyktu. March 18, 2026 · 2 min read · Tristan Manalac Read more Despite these key advantages for Skyrizi, “we remain positive on the commercial opportunity presented by Icotyde as the first and only oral IL-23 on the market,” BMO stated in its Friday note. J&J and Protagonist are also proposing Icotyde for psoriasis more broadly, an “already large” market that could unlock billions in opportunity for the drug. Peak psoriasis sales for the pill could hit $3.2 billion in 2040, the firm forecasted. Another plaque psoriasis player is Takeda, though the pharma is far behind AbbVie and J&J, with its TYK2 inhibitor zasocitinib still in Phase 3 development. Data from a pair of late-stage studies, presented Saturday at the American Academy of Dermatology Annual Meeting, showed that daily doses of zasocitinib induced clear or almost clear skin in 69.2% to 71.4% of patients, as compared with 10.7% to 12.6% of placebo comparators and 29.7% to 32.1% of those on Amgen’s Otezla. PASI-90 was likewise significantly higher in the zasocitinib arms versus placebo and Otezla. Takeda plans to zasocitinib’s approval during its fiscal year 2026, which starts on April 1.

The US FDA has approved Icotyde (icotrokinra) for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients aged 12 years and older weighing at least 40 kg who are candidates for systemic therapy or phototherapy. The approval, announced by Johnson & Johnson (J&J), marks the first oral peptide to target the interleukin-23 (IL-23) receptor to reach the market. The drug was jointly discovered by Protagonist Therapeutics and Janssen Biotech under a license and collaboration agreement first established in 2017 and subsequently expanded. J&J holds worldwide rights to develop and commercialize the compound. Icotyde is administered as a once-daily 200 mg oral tablet taken on an empty stomach. The approved indication covers patients who are candidates for systemic therapy or phototherapy, positioning it as a first-line systemic option. The prescribing information notes infection risk as the primary safety concern, consistent with other agents that modulate IL-23 signaling, and advises screening for tuberculosis prior to treatment initiation. The label also includes a pediatric indication from launch, covering adolescents aged 12 and older at or above 40 kg, a population not covered by the only other oral systemic approved in this space, Bristol Myers Squibb’s deucravacitinib (Sotyktu). The approval rests on four Phase III studies from the ICONIC clinical development program, which enrolled approximately 2,500 patients. Two of these, ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2, were duplicate head-to-head trials comparing icotrokinra with both placebo and deucravacitinib. At Week 16, approximately 70% of icotrokinra-treated patients achieved clear or almost clear skin as measured by IGA 0/1, and 55% achieved PASI 90. The ICONIC-LEAD trial evaluated efficacy and safety against placebo in adults and adolescents, while ICONIC-TOTAL assessed outcomes in patients with psoriasis affecting high-impact sites including scalp, genital, and palmoplantar areas. Across the program, adverse reaction rates in icotrokinra-treated patients were within 1.1% of placebo through Week 16, the company said, and no new safety signals emerged through Week 52. The approval enters a treatment landscape already populated by injectable IL-23 inhibitors such as guselkumab and risankizumab, IL-17 inhibitors including secukinumab and ixekizumab, and the dual IL-17A/F inhibitor bimekizumab, approved in 2023. Deucravacitinib, a selective TYK2 inhibitor approved in September 2022, was the first oral targeted therapy in this space but acts through a distinct mechanism. Icotyde is differentiated by its modality — an orally bioavailable peptide that binds the IL-23 receptor and inhibits downstream signaling — rather than targeting the cytokine itself or upstream kinases. The head-to-head design against deucravacitinib in the ICONIC-ADVANCE studies provides direct comparative data that may inform treatment sequencing, though full publications of these results are awaited. The label also includes a pediatric indication from launch, covering adolescents aged 12 and older weighing at least 40 kg. Unlike Bristol Myers Squibb’s deucravacitinib, which is approved only in adults for plaque psoriasis, icotrokinra enters the market with adolescent labeling; however, apremilast is already approved as an oral systemic option for pediatric plaque psoriasis in younger patients. The pipeline behind Icotyde remains active: J&J continues to study the molecule in psoriatic arthritis, ulcerative colitis, and Crohn’s disease. Also under development are next-generation TYK2 inhibitors from Takeda and Alumis, both in Phase III, and oral IL-17A inhibitors in earlier development. Psoriasis affects an estimated 8 million Americans, and nearly 25% of cases are classified as moderate-to-severe. For patients who cycle through topical therapies without adequate control, the availability of an oral agent targeting the IL-23 receptor adds a mechanistically distinct systemic option to existing injectable and oral alternatives. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website