Tremfya Approved for Moderately to Severely Active Crohn Disease

What To Know

FDA approved Tremfya (guselkumab), an IL-23 inhibitor, for adults with moderately to severely active Crohn disease. The approval was based on phase 3 trials (GALAXI 2, GALAXI 3, and GRAVITI) that evaluated IV and subcutaneous induction regimens and showed greater rates of clinical remission and endoscopic response with guselkumab versus placebo.

The drug is available for IV induction by a health care provider or SC induction/maintenance by patient or caregiver after training. Common adverse reactions reported included respiratory tract infections, abdominal pain, injection-site reactions, headache, fatigue, arthralgia, diarrhea, and gastroenteritis.

This article summarizes the FDA approval and highlights that Tremfya is currently the only IL-23 inhibitor with both IV and SC induction options for Crohn disease. It references the company news release and prescribing information as the sources for dosing forms and trial results.

If you or your clinician are considering treatment options, this approval expands the biologic choices for moderate-to-severe Crohn disease and may be especially relevant for people who need or prefer an IV induction option. Discuss with your care team whether guselkumab is appropriate given prior treatments, medical history, and potential side effects.