SPRING HOUSE, PA — Johnson & Johnson (NYSE: JNJ) said the U.S. Food and Drug Administration has approved ICOTYDE (icotrokinra) for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients age 12 and older who weigh at least 40 kilograms.
The drug is an oral interleukin-23 receptor antagonist intended for patients eligible for systemic therapy or phototherapy, offering a once-daily treatment option.
The approval is based on data from multiple Phase 3 clinical trials involving about 2,500 patients, which evaluated the drug’s safety and effectiveness.
In head-to-head studies, about 70% of patients receiving ICOTYDE achieved clear or nearly clear skin, while 55% reached at least a 90% improvement in disease severity scores at 16 weeks, according to the company.
Adverse reaction rates were comparable to placebo through 16 weeks, and no new safety concerns were identified through 52 weeks.
“ICOTYDE delivers something unique in psoriasis treatment – combining skin clearance with a favorable safety profile in a once-daily pill,” said Dr. Linda Stein Gold, a dermatology researcher at Henry Ford Health.
Psoriasis affects more than 8 million people in the United States, with moderate-to-severe cases often requiring systemic treatment beyond topical therapies.
“The approval of a novel systemic therapy changes the conversation about treatment options for our community,” said Leah M. Howard, president and CEO of the National Psoriasis Foundation.
ICOTYDE is designed to block the IL-23 receptor, which plays a role in the inflammatory response associated with plaque psoriasis.
Johnson & Johnson said the drug is part of its broader research efforts targeting immune-mediated diseases and is also being studied for use in psoriatic arthritis, ulcerative colitis, and Crohn’s disease.
More information is available at www.icotyde.com.
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