FDA Approves J&J's Icotyde for Plaque Psoriasis

The U.S. Food and Drug Administration approved Johnson & Johnson's once-daily oral pill Icotyde on Wednesday for treating moderate to severe plaque psoriasis in adults and children ages 12 and older who weigh at least 40 kilograms and are candidates for systemic therapy or phototherapy.

The approval marks the first oral therapy targeting the interleukin-23 receptor, a protein involved in the inflammatory response that drives psoriasis, an autoimmune condition affecting about 8 million people in the United States. Psoriasis causes rapid buildup of skin cells, leading to itchy, scaly, inflamed patches that can cause physical discomfort, joint pain, and emotional distress from symptoms like burning skin and embarrassment. The disease often emerges between ages 10 and 35, with genetic factors and triggers such as stress, infections, or cold weather contributing to flare-ups.

Icotyde, chemically known as icotrokinra and developed in partnership with Protagonist Therapeutics, offers an alternative to injectable treatments like Johnson & Johnson's Tremfya and AbbVie's Skyrizi, which also target the IL-23 pathway but require needles. Officials at Johnson & Johnson described the pill as...