Johnson & Johnson has announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the approval of icotrokinra, a first-in-class investigational oral peptide designed to treat moderate-to-severe plaque psoriasis in adults and adolescents. This submission is based on a comprehensive data package that demonstrated the drug's efficacy and safety across several Phase 3 studies, including head-to-head superiority comparisons with deucravacitinib. The results showed significant skin clearance and a favorable safety profile, with icotrokinra meeting all primary endpoints. The company aims to shift the treatment paradigm for plaque psoriasis with this once-daily pill, and the FDA review is currently ongoing.
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