Johnson & Johnson Submits New Drug Application to FDA for First Approval of Icotrokinra, Aiming to Transform Plaque Psoriasis Treatment

Reuters
07/21
Johnson & Johnson Submits New Drug Application to FDA for First Approval of Icotrokinra, Aiming to Transform Plaque Psoriasis Treatment

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.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Johnson & Johnson published the original content used to generate this news brief via PR Newswire (Ref. ID: NY32934) on July 21, 2025, and is solely responsible for the information contained therein.

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