J&J : FDA Approves TREMFYA For Adult Patients With Moderately To Severely Active Crohn's Disease

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(RTTNews) - Johnson & Johnson (JNJ) announced that the U.S. Food and Drug Administration has approved TREMFYA (guselkumab), the first and only IL-23 inhibitor offering both subcutaneous (SC) and intravenous (IV) induction options, for the treatment of adults with moderately to severely active Crohn's disease or CD, a chronic inflammatory condition of the gastrointestinal tract.

This milestone builds upon the FDA approval of TREMFYA in moderately to severely active ulcerative colitis (UC), one of two main forms of inflammatory bowel disease (IBD), which impacts the lives of nearly three million Americans.

TREMFYA is the first and only approved fully-human, dual-acting monoclonal antibody that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23. IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases including CD.

TREMFYA dosing in the treatment of moderately to severely active CD: The recommended SC induction dosage is 400 mg (given as two consecutive injections of 200 mg each, dispensed in one Induction Pack) at Weeks 0, 4 and 8. TREMFYA is also available in a 200 mg prefilled syringe. For the IV induction option, 200 mg IV infusions are administered at Weeks 0, 4 and 8.

Recommended maintenance dosage is 100 mg administered by SC injection at Week 16, and every 8 weeks thereafter, or 200 mg administered by SC injection at Week 12, and every 4 weeks thereafter. Healthcare providers are instructed to use the lowest effective recommended dosage to maintain therapeutic response.

The latest FDA approval marks the fourth indication for TREMFYA in the U.S., following moderate-to-severe plaque psoriasis in July 2017, active psoriatic arthritis in July 2020 and moderately to severely active UC in September 2024,6 underscoring Johnson & Johnson's long-standing legacy in innovation and commitment to patients living with chronic immune-mediated diseases, including IBD. In November 2024, Johnson & Johnson submitted a supplemental Biologics License Application (sBLA) to the FDA seeking approval of a SC induction regimen of TREMFYA for the treatment of adults with moderately to severely active UC, based on results of the Phase 3 ASTRO study.

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