ICOTYDE receives approval for first in line systemic treatment of plaque psoriasis with a targeted oral peptide

Johnson & Johnson has recently announced that the U.S. FDA has approved ICOTYDE, which is an interleukin-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 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.^a “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
Note that ICOTYDE met all primary efficacy endpoints and demonstrated a favorable safety profile across four Phase 3 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.

“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.”

 

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Related Topics and Keywords

ICOTYDE, Johnson and Johnson, oral peptide, Plaque Psoriasis