by Lori Solomon

The U.S. Food and Drug Administration has approved Johnson & Johnson’s Tremfya (guselkumab) for adult patients with moderately to severely active Crohn disease.

This approval is the fourth indication for this dual-acting interleukin-23 inhibitor in the United States, making Tremfya the first and only interleukin-23 inhibitor offering both subcutaneous and intravenous induction options for adults with Crohn disease.

The approval is based on data from three Phase III trials. In the GRAVITI study, Tremfya (400 mg subcutaneous induction at weeks 0, 4, and 8) led to significantly higher clinical remission (56 versus 22%) and endoscopic response (34 versus 15%) when compared with placebo. Similar results were seen in the GALAXI 2 and GALAXI 3 trials, which compared Tremfya 200 mg intravenous induction at weeks 0, 4, and 8 with placebo.

“Despite the progress in the management of Crohn’s disease, many patients experience debilitating symptoms and are in need of new treatment options,” lead investigator of the GRAVITI study, Remo Panaccione, M.D., from the University of Calgary in Alberta, Canada, said in a statement.

“Importantly, the fully subcutaneous regimen offers choice and flexibility for patients and providers that have not been available before.”

More information: More Information

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