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FDA OKs Guselkumab for Crohn's Disease - Medscape
An FDA approval means guselkumab (Tremfya) is now an approved treatment option for adults with moderate-to-severe Crohn’s disease, including a unique option for fully subcutaneous induction. This may expand choices for patients who have not responded to other therapies.
Adults with moderate-to-severe Crohn’s disease, patients who failed prior biologics or immunomodulators, clinicians treating IBD, and researchers interested in IL-23 therapies.
What To Know
The FDA approved guselkumab (Tremfya) for adults with moderate to severe Crohn’s disease.
The approval is based on phase 3 trials (GRAVITI, GALAXI 2, GALAXI 3) showing superiority to placebo and to ustekinumab on endoscopic endpoints, and the drug can be given either as a fully subcutaneous induction regimen or as an IV induction followed by subcutaneous maintenance.
Dosing options described in the source: SC induction 400 mg (two 200 mg injections) at weeks 0, 4, 8; IV induction 200 mg at weeks 0,4,8; maintenance options include 100 mg SC every 8 weeks (start week 16) or 200 mg SC every 4 weeks (start week 12). Guselkumab is now an FDA-approved IL-23 inhibitor option for adults with moderate to severe Crohn’s disease.
The approval expands treatment choices and is notable because it offers both IV and fully subcutaneous induction approaches. If you are already on biologic therapy or have failed other therapies, this approval may be relevant; talk with your clinician about whether this option fits your situation.
Adults with moderate-to-severe Crohn’s disease, people who have failed or are intolerant to corticosteroids, immunomodulators, or prior biologics, clinicians managing IBD, and IBD researchers.
The article summarizes a company news release and trial results; full prescribing information and medication guide are available on the FDA label and manufacturer websites. This is an approval announcement — individual treatment decisions should be made with a clinician, and the article does not replace product labeling or personalized medical advice.
Approval is based on phase 3 trials reported by the company and summarized in the article; consult the full prescribing information and discuss risks and benefits with a clinician. The article is a news summary and draws on company statements and trial names rather than providing full primary data.
