Johnson & Johnson announced on Monday, September 21, 2026 that the European Commission granted marketing authorization for ICOTYDE (icotrokinra) for adults and adolescents aged 12 and older weighing at least 40 kg with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. J&J calls icotrokinra the first targeted oral peptide that precisely blocks the IL-23 receptor; it was jointly discovered and is being developed under J&J's license and collaboration agreement with Protagonist Therapeutics. The approval rests on the ICONIC program of four Phase 3 studies in about 2,500 patients (ICONIC-LEAD, ICONIC-TOTAL, ICONIC-ADVANCE 1 and 2). In the head-to-head studies, about 70% of patients on icotrokinra reached clear or almost clear skin (IGA 0/1) and 55% reached PASI 90 at week 16. Patients take one pill once daily with water on waking, at least 30 minutes before eating.
Johnson & Johnson (NYSE: JNJ) received FDA approval Wednesday August 26, 2026 for Imaavy (nipocalimab), an anti-neonatal Fc receptor (FcRn) monoclonal antibody administered as subcutaneous injection, for the treatment of warm autoimmune hemolytic anemia (wAIHA) in adults and pediatric patients aged 12 and older. Disease context: wAIHA is a rare autoimmune disease in which autoantibodies (primarily IgG) bind red blood cells at body temperature and trigger complement- and macrophage-mediated red blood cell destruction, causing fatigue, jaundice, splenomegaly, and in severe cases life-threatening anemia. Prior treatment has relied on corticosteroids, rituximab (an anti-CD20 monoclonal antibody), splenectomy, and other immunosuppressants, all with substantial side effects and variable efficacy. Nipocalimab mechanism: blocks the neonatal Fc receptor (FcRn) that normally rescues IgG antibodies from degradation; blocking FcRn accelerates IgG catabolism and reduces the pathogenic IgG autoantibody burden that drives wAIHA. The Imaavy approval extends the anti-FcRn therapeutic category that argenx pioneered with Vyvgart (efgartigimod alfa, IV and SC formulations) into a new autoimmune indication beyond the currently-approved indications of generalized myasthenia gravis and chronic inflammatory demyelinating polyneuropathy. The FcRn category is a growing modality with multiple companies pursuing autoimmune indications; J&J's Imaavy is now approved for wAIHA and separately in myasthenia gravis, positioning as a direct competitor to argenx's Vyvgart franchise. Approval was supported by Phase 3 clinical data documenting substantial improvements in hemoglobin levels and transfusion-independence rates compared to placebo.