Protagonist Therapeutics announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for icotrokinra. The application seeks approval for the treatment of adults and adolescents 12 years of age and older with moderate-to-severe plaque psoriasis.
Icotrokinra is a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor. The NDA submission is based on an unprecedented data package that met all primary endpoints across four Phase 3 studies, including head-to-head superiority data against a competitor.
This regulatory filing represents a significant milestone for Protagonist and its partner Johnson & Johnson, moving icotrokinra closer to potentially revolutionizing the treatment paradigm for plaque psoriasis patients. The submission underscores the robust clinical profile demonstrated by the comprehensive Phase 3 program.
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