FDA Approves J&J’s Icotyde for Plaque Psoriasis

FDA has approved Johnson & Johnson’s Icotyde (icotrokinra) to treat moderate-to-severe plaque psoriasis in adults and some pediatric patients aged 12 and older who are candidates for systemic therapy or phototherapy. A company statement says Icotyde is the only targeted oral peptide that precisely blocks the IL-23 receptor.

J&J says Icotyde met all primary efficacy endpoints and demonstrated a favorable safety profile across four ICONIC Phase 3 studies, including 2,500 patients.

Icotyde is described as the first and only targeted oral peptide designed to precisely block the IL-23 receptor, which underpins the inflammatory response in moderate-to-severe plaque psoriasis. It binds to the IL-23 receptor with high affinity and demonstrates potent inhibition of IL-23 signaling in human T-cells, J&J says.

The company says it is also studying Icotyde in active psoriatic arthritis, moderately-to-severely active ulcerative colitis, and moderately-to-severely active Crohn’s disease.