Protagonist Therapeutics announced the submission of an application for approval of icotrokinra in plaque psoriasis to the European Medicines Agency (EMA). This marks a significant step towards potentially bringing the oral peptide to patients in Europe.
Icotrokinra is a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor. The application is based on a comprehensive data package from four Phase 3 studies, which met all primary and co-primary endpoints.
This submission follows the earlier U.S. FDA NDA filing and includes head-to-head superiority data against a competitor. The European regulatory process is a crucial pathway for expanding the commercial reach of icotrokinra.
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