FDA approves once daily pill Icotyde for plaque psoriasis

The FDA has approved Johnson and Johnson’s Icotyde (icotrokinra) for the treatment of moderate-to-severe plaque psoriasis in adult and pediatric patients ages 12 and older weighing at least 88 lbs., according to a news release published today. Patients interested in Icotyde must be candidates for systemic therapy or phototherapy.

This approval makes Icotyde the first and only interleukin-23 (IL-23) receptor antagonist for this indication.

Plaque psoriasis is a chronic autoimmune condition that results in the overproduction of skin cells, which appear as itchy, thick white and red skin patches, typically on the elbows, knees, scalp and face. This disease affects more than 8 million Americans and more than 125 million patients worldwide. There are multiple types of psoriasis, the most common being plaque psoriasis, which makes up 90% of cases and approximately one-quarter of plaque psoriasis patients have cases that are considered to be moderate-to-severe. The condition can cause pain, discomfort, and social or emotional distress, particularly when lesions appear on highly visible areas of the body, significantly impacting daily life.

"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," Leah M. Howard, J.D., president and CEO of the National Psoriasis Foundation, said in the news release. ”The approval of a novel systemic therapy changes the conversation about treatment options for our community."

This approval was made using the results of four phase 3 clinical studies that included 2,500 patients. Approximately 70% of patients achieved clear or almost clear skin and 55% of patients achieved a Psoriasis Area and Severity Index response of 90 at week 16. The studies also demonstrated efficacy in difficult-to-treat areas, such as the scalp, genitals and hands, highlighting Icotyde’s broad effectiveness across body regions. Adverse reactions were reported in at least 1% of participants, including headache, nausea and cough.

Icotyde works by blocking the interleukin-23 (IL-23) receptor, a key part of the immune system that drives inflammation in plaque psoriasis. By binding to this receptor, the drug prevents IL-23 from activating immune cells, which in turn reduces the release of inflammatory signals responsible for rapid skin cell growth and plaque formation. This helps calm the overactive immune response underlying psoriasis and leads to clearer skin. Unlike many existing treatments that target IL-23 itself, ICOTYDE is a once-daily oral peptide that blocks the receptor directly.

Icotyde should be taken on an empty stomach with water upon waking. For those who have difficulty swallowing pills, Icotyde can be dissolved in 4 oz. of water. The patient should wait at least 30 minutes before consuming food.

"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., Director of Dermatology Clinical Research at Henry Ford Health, said in the news release. "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."