Protagonist Submits NDA for Icotrokinra to FDA

Protagonist Therapeutics has filed a New Drug Application (NDA) with the U.S. FDA for icotrokinra, an investigational oral peptide targeting the IL-23 receptor, developed in collaboration with Johnson & Johnson. This submission aims to secure the first U.S. approval for treating moderate-to-severe plaque psoriasis in patients aged 12 and older.

The NDA features data from four pivotal Phase 3 studies under the ICONIC program. Icotrokinra met all primary endpoints, demonstrating skin clearance and a favorable safety profile. It was shown to be superior to deucravacitinib in head-to-head trials and had similar adverse event rates as those observed with placebo.

This filing highlights the potential of icotrokinra to change the therapeutic landscape for psoriasis by offering an effective, convenient oral alternative. Protagonist anticipates extending icotrokinra applications to other IL-23-mediated conditions such as psoriatic arthritis and ulcerative colitis.