The U.S. Food and Drug Administration (FDA) has granted approval for guselkumab (Tremfya, Johnson & Johnson) as a treatment for adults with moderately to severely active Crohn’s disease (CD).
This approval marks the fourth indication for guselkumab, which was previously approved for moderate to severe plaque psoriasis in 2017, active psoriatic arthritis in 2020, and moderately to severely active ulcerative colitis in 2024.
Guselkumab is the first and only interleukin-23 (IL-23) inhibitor to offer both subcutaneous (SC) and intravenous (IV) induction options for CD treatment, according to a company statement.
Dr. Remo Panaccione, Director of the Inflammatory Bowel Disease Unit at the University of Calgary, emphasized the significance of this approval. “Despite advancements in Crohn’s disease management, many patients continue to experience debilitating symptoms and require new treatment options,” he said. “The approval of Tremfya introduces an IL-23 inhibitor that has demonstrated robust rates of endoscopic remission with both subcutaneous and intravenous induction regimens. Additionally, the fully subcutaneous regimen provides flexibility and choice for patients and healthcare providers.”
The FDA’s decision was based on promising results from three Phase 3 clinical trials involving over 1,300 patients with moderately to severely active CD who had either failed or were intolerant to corticosteroids, immunomodulators, or biologic therapies.
Key findings from the GRAVITI trial revealed that guselkumab, when used for SC induction and maintenance therapy, was superior to placebo in achieving clinical remission, as well as in endoscopic response, remission, and deep remission.
Results from the GALAXI 2 and GALAXI 3 trials demonstrated that guselkumab outperformed ustekinumab (Stelara) on all pooled endoscopic endpoints.
Guselkumab is the only IL-23 inhibitor to show clinical remission and endoscopic response, both at one year, with a fully subcutaneous induction regimen, the company noted.
The recommended SC induction dose of guselkumab is 400 mg, administered as two consecutive 200 mg injections, given at weeks 0, 4, and 8. The drug is also available in a 200 mg prefilled syringe. For the IV induction option, 200 mg is given as an IV infusion at weeks 0, 4, and 8.
For maintenance, the recommended dosage is either 100 mg administered via SC injection at week 16, followed by every 8 weeks thereafter, or 200 mg administered via SC injection at week 12, followed by every 4 weeks thereafter. It is advised to use the lowest effective dose to maintain therapeutic response.
This approval provides new hope for patients with Crohn’s disease, offering a flexible treatment option with demonstrated efficacy.
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