Global pharma giant Johnson & Johnson has announced that the US Food and Drug Administration has approved its oral ICOTYDE (icotrokinra), offering a targeted approach to treating moderate-to-severe plaque psoriasis.
ICOTYDE is a groundbreaking interleukin-23 (IL-23) receptor antagonist for adults and pediatric patients 12 years and older who weigh at least 40 kg and are candidates for systemic therapy or phototherapy. ICOTYDE is the first and only oral peptide therapy that directly blocks the IL-23 receptor.
“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,” said Linda Stein Gold, Director of Dermatology Clinical Research at Henry Ford Health.
“With new guidance from the International Psoriasis Council that clarifies when to move beyond cycling on topical treatments to systemic therapy, an innovative option like ICOTYDE is a potential game‑changer for many adult and adolescent patients.”
The approval is supported by robust data from four Phase 3 trials including 2,500 patients. ICOTYDE met all primary efficacy endpoints, demonstrating strong results across adult and adolescent populations, high-impact sites such as scalp and genital psoriasis, and in head-to-head trials versus active comparators.
In these studies, roughly 70% of patients achieved clear or almost clear skin, and 55% reached a 90% improvement in the Psoriasis Area and Severity Index (PASI 90) by Week 16. Rates of adverse reactions were comparable to placebo, and no new safety signals emerged through Week 52.
“With the FDA approval of ICOTYDE, Johnson & Johnson is setting a new standard for the treatment of moderate-to-severe plaque psoriasis,” said Jennifer Taubert, Executive Vice President, Worldwide Chairman, Innovative Medicine, Johnson & Johnson.
“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.”
Psoriasis affects millions worldwide.
“The approval of ICOTYDE represents a pivotal moment for people with plaque psoriasis,” said John Reed, Executive Vice President, R&D, Innovative Medicine, Johnson & Johnson.
“At Johnson & Johnson, we are harnessing our scientific expertise to transform cutting-edge science into meaningful solutions for patients. ICOTYDE is a fundamentally different treatment with the potential to redefine what physicians and patients can expect from psoriasis treatment.”
