FDA approves Icotyde (icotrokinra) for first-line systemic treatment of plaque psoriasis with a targeted oral peptide – Johnson & Johnson
Johnson & Johnson announced that the FDA has approved Icotyde (icotrokinra), an interleukin-23 (IL-23) receptor antagonist for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg who are candidates for systemic therapy or phototherapy. Icotyde is the first and only targeted oral peptide that precisely 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, M.D., 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.”
Clinical evidence summary
Icotyde met all primary efficacy endpoints and demonstrated a favorable safety profile across four Phase III studies including 2,500 patients. The approval is based on an unprecedented body of evidence from the ICONIC clinical development program, which simultaneously evaluated Icotyde in adults and adolescents, high impact sites such as scalp and genital PsO, and in duplicate head-to-head trials versus an active comparator. In the head-to-head superiority studies, approximately 70% of patients achieved clear or almost clear skin (IGA 0/1) and 55% of patients achieved a Psoriasis Area and Severity Index (PASI) 90 response at Week 16. Rates of adverse reactions for Icotyde treated patients were within 1.1% of placebo through Week 16 and no new safety signals were identified 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.”
Unmet need in moderate-to-severe plaque psoriasis
Psoriasis affects more than 8 million Americans, impacting physical comfort and quality of life, especially when lesions are on visible or sensitive areas. For many with moderate-to-severe disease, targeted systemic treatments are key. This aligns with International Psoriasis Council guidance to transition to systemic therapy if two cycles of topical medications applied for four weeks fail to bring meaningful improvement.
“Finding the right treatment can take time, during which people with psoriatic disease should be considering multiple factors from efficacy to safety to how the treatment fits into their everyday life,” said Leah M. Howard, J.D., President and CEO of the National Psoriasis Foundation. “The approval of a novel systemic therapy changes the conversation about treatment options for our community.”
“The approval of Icotyde represents a pivotal moment for people with plaque psoriasis,” said John Reed, M.D., Ph.D., 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.”
About the ICONIC Clinical Development Program
The pivotal Phase III ICONIC clinical development program includes five Phase III studies of Icotyde in patients 12 and older with moderate-to-severe plaque PsO.
ICONIC-LEAD (NCT06095115) is a randomized clinical trial (RCT) to evaluate the efficacy and safety of Icotyde compared with placebo in participants with moderate-to-severe plaque PsO, with PASI 90 and IGA score of 0 or 1 with at least a 2-grade improvement as co-primary endpoints.
ICONIC-TOTAL (NCT06095102) is a RCT to evaluate the efficacy and safety of Icotyde compared with placebo for the treatment of PsO in participants with at least moderate severity affecting special areas (e.g., scalp, genital, and/or hands and feet) with overall IGA score of 0 or 1 with at least a 2-grade improvement as the primary endpoint.
ICONIC-ADVANCE 1 (NCT06143878) and ICONIC-ADVANCE 2 (NCT06220604) are RCTs to evaluate the efficacy and safety of Icotyde compared with both placebo and deucravacitinib in adults with moderate-to-severe plaque PsO.
ICONIC-ASCEND (NCT06934226) is a RCT to evaluate the efficacy and safety of Icotyde compared with placebo and ustekinumab in participants with moderate-to-severe plaque psoriasis.
