pharmaphorum.com
J&J adds to IL-23 options in Crohn's after FDA approval
A newly FDA‑approved IL‑23 drug for Crohn’s may increase treatment options for people with IBD, including an IV and a subcutaneous formulation. The approval could affect switching decisions for patients not responding to current biologics and changes the competitive landscape among IL‑23 therapies.
Adults with Crohn’s disease or ulcerative colitis, patients considering or already on biologic/IL‑23 therapies, gastroenterologists, and researchers tracking IBD drug development and market access.
What To Know
Tremfya (guselkumab) has received FDA approval for Crohn’s disease, giving Johnson & Johnson an IL-23 option available in both IV and subcutaneous formulations for IBD.
The article notes J&J’s claims about Tremfya’s year‑one remission and endoscopic response on a fully subcutaneous regimen and references the GRAVITI and GALAXI studies, including a reported superiority to Stelara (ustekinumab) on pooled endoscopic endpoints in GALAXI.
The piece places Tremfya in the competitive context of other IL‑23 drugs—Skyrizi (risankizumab), Omvoh (mirikizumab), and Ilumya (tildrakizumab)—and mentions commercial sales and market projections.
This is a regulatory approval and commercial analysis based on company statements and pivotal trials (GRAVITI, GALAXI). The article reports company claims about efficacy and cites head‑to‑head trial results; readers should consult primary trial publications and clinical guidance for detailed efficacy and safety data.
Approval does not imply one drug is superior for all patients.
