FDA Approves Icotrokinra for Plaque Psoriasis Save

Today the FDA approved an oral IL-23 inhibitor, icotrokinra (Icotyde), for use in moderate-to-severe plaque psoriasis in adults and children 12 years of age and older (who weigh at least 40 kg) who are candidates for systemic therapy or phototherapy, according to a press release from Johnson & Johnson. Icotrokinra is novel in that it is the only oral peptide targeting the IL-23 receptor.

Approval is based on results from "ICONIC" clinical trial program demonstrating primary efficacy and a favorable safety profile. These four Phase 3 studies, involved 2,500 adults and adolescents with active plaque psoriasis (PSO), and included studies involving scalp and genital PsO, and head-to-head studies against deucravacitinib, and another against ustekinumab.  In these trials approximately 70% of patients achieved clear or almost clear skin and 55% of patients achieved a Psoriasis Area and Severity Index (PASI) 90 response at Week 16.

The most common side effects of icotrokinra include headache, nausea, cough, fungal infection, and fatigue.  The product label nonetheless has the usual warnings about risk of serious infections (avoid or discontinue with active infection, tuberculosis (consider TB testing  prior to initiating treatment), and Immunizations (avoid live vaccine use with the drug). 

Icotrokinra is only approved for active PSO, and is not approved for use in psoriatic arthritis (PsA). Yet, Icotrokinra is being studied in inflammatory bowel disease and ulcerative colitis and active PsA.