FDA Approves Icotyde for Moderate-to-Severe Plaque Psoriasis

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By Lori Solomon HealthDay Reporter

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Medically reviewed by Drugs.com

via HealthDay

TUESDAY, March 24, 2026 -- The U.S. Food and Drug Administration 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 aged 12 years and older.

Icotyde is the first and only targeted oral peptide that blocks the IL-23 receptor and is approved for patients weighing ≥40 kg who are candidates for systemic therapy or phototherapy.

The approval was based on four phase 3 studies involving 2,500 patients. In the head-to-head superiority studies, approximately 70 percent of patients treated with Icotyde achieved clear or almost clear skin (Investigator's Global Assessment 0/1), and 55 percent of patients achieved a Psoriasis Area and Severity Index 90 response at week 16 versus an active comparator. Through week 16, rates of adverse reactions among Icotyde-treated patients were within 1.1 percent of placebo through week 16, with no new safety signals identified through week 52.

"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," Linda Stein Gold, M.D., from Henry Ford Health and a Johnson & Johnson consultant, said in a statement. "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 of Icotyde was granted to Johnson & Johnson.

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Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.

Source: HealthDay

Posted : 2026-03-25 08:53

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