The U.S. Food and Drug Administration on Wednesday approved Johnson & Johnson’s oral pill for psoriasis, the company said.
In a news release, Johnson & Johnson said that the FDA approved Icotyde (icotrokinra) to treat moderate to severe plaque psoriasis in adults and pediatric patients 12 years and older who weight at least 88 pounds.
It is the first oral peptide that precisely blocks the IL-23 receptor, the company said.
The pill was approved based on data from studies in the phase 3 Iconic clinical development program, according to the American Journal of Managed Care.
The Iconic program evaluated icotrokinra in adults and adolescents, included high-impact sites such as scalp and genital plaque psoriasis, and included head-to-head trials against an active comparator, the publication reported.
Icotyde will compete with Sotyktu, manufactured by Bristol Myers Squibb; and Skyrizi, made by AbbVie, Reuters reported.
“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, the director of dermatology clinical research at Henry Ford Health, 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.”
Jennifer Taubert, Johnson & Johnson’s executive vice president for innovative medicine, said the company was “setting a new standard” to treat psoriasis patients.
“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,” she said in a statement.
Patients with psoriasis typically use topical drugs before receiving an injection for the condition. Many potential patients decide against those options due to cost or for reasons of convenience.
Johnson & Johnson is developing the oral drug in a partnership with Protagonist Therapeutic, Reuters reported.
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