Johnson & Johnson (J&J) has received US Food and Drug Administration (FDA) approval for its interleukin 23 inhibitor, Tremfya (guselkumab), to treat moderately to severely active Crohn’s disease (CD) in adults.
The approval introduces the therapy with both subcutaneous (SC) and intravenous (IV) induction alternatives for this gastrointestinal tract’s chronic inflammatory condition.
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The fully human dual-acting monoclonal antibody attaches to the cluster of differentiation 64, targeting inflammation at its cellular source.
This milestone follows the drug’s previous approval from the agency for ulcerative colitis, another form of inflammatory bowel disease.
The latest decision is based on the outcomes from several Phase III trials, which comprised more than 1,300 CD subjects who were not tolerant to conventional treatments or biologics.
The GRAVITI trial evaluated SC induction of the antibody and maintenance therapy against a placebo.
GALAXI clinical programme data revealed that the antibody was superior to Stelara across all pooled endoscopic endpoints.
The comprehensive findings from these Phase III trials showcased the efficacy of both SC and IV formulations of the antibody in meeting endoscopic and clinical endpoints.
J&J innovative medicine gastroenterology and autoantibody medical affairs vice-president Chris Gasink stated: “With the approval of Tremfya, it is now possible to achieve meaningful improvements in clinical and endoscopic outcomes with the flexibility of self-administration from the start.
“Tremfya provides people living with CD and their healthcare providers a new treatment option that is supported by data from multiple Phase III studies, including pooled analyses showing statistical superiority versus Stelara across four endoscopic or combined clinical and endoscopic endpoints.”
Tremfya’s latest approval marks its fourth indication in the country.
In November 2024, the company submitted a supplemental biologics licence application to the US regulator for an SC induction regimen of the antibody for UC.
In January, 2025, J&J’s nasal spray Spravato secured a label expansion from the FDA for use as a single agent in adults with major depressive disorder (who were not responsive to two oral antidepressants.
