The US Food and Drug Administration has approved icotrokinra (ICOTYDE), an oral interleukin-23 receptor antagonist, for adults and pediatric patients aged 12 years and older who weigh at least 40 kg with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, according to a press release from Johnson & Johnson.
Icotrokinra is a targeted oral peptide that inhibits the interleukin-23 receptor, a pathway involved in inflammatory signaling in plaque psoriasis, and represents a new therapeutic approach in this setting. The once-daily oral formulation may provide an alternative to injectable biologic therapies, particularly for patients who have not achieved sufficient disease control with topical treatments.
Regulatory approval was informed by findings from the phase 3 ICONIC clinical development program, which enrolled about 2,500 patients and included both adult and adolescent populations, as well as patients with involvement of high-impact areas such as the scalp and genital regions. In head-to-head studies, treatment with icotrokinra resulted in clear or nearly clear skin in roughly 70% of patients, while about 55% achieved at least a 90% reduction in disease severity at week 16.
Adverse event rates were similar to placebo through week 16, and no new safety signals were reported through week 52. The most commonly reported adverse events included headache, nausea, cough, fatigue, and fungal infection. The prescribing information notes that treatment may be associated with infections and notes that patients should be monitored for signs of infection, including tuberculosis.
Plaque psoriasis affects more than 8 million people in the US and can affect physical comfort and quality of life, particularly when lesions involve visible or sensitive areas such as the scalp, hands, feet, or genitals. The International Psoriasis Council recommends transitioning to systemic therapy when two cycles of topical treatment applied over four weeks do not result in meaningful improvement.
Source: Johnson and Johnson
