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FDA Approves TREMFYA®: A New Hope for Crohn's Disease Patients

On March 20, 2025, Johnson & Johnson announced a significant milestone in the treatment of Crohn's disease as the U.S. Food and Drug Administration (FDA) granted approval for TREMFYA® (guselkumab). This approval marks TREMFYA® as the first and only IL-23 inhibitor that can be administered through both subcutaneous (SC) and intravenous (IV) routes, catering to the needs of patients with moderately to severely active Crohn's disease.

Crohn's disease, a chronic inflammatory condition affecting the gastrointestinal tract, impacts nearly three million Americans. Unfortunately, current treatment options often fall short, leaving many patients struggling with debilitating symptoms. The approval of TREMFYA® is a welcome development for these individuals, as it offers a potent new treatment avenue.

How TREMFYA® Works

TREMFYA® is a fully human monoclonal antibody designed to neutralize inflammation at the source by blocking IL-23 and engaging with a receptor (CD64) that mediates IL-23 production. IL-23 is a cytokine that plays a significant role in the pathogenesis of immune-mediated diseases, including Crohn's disease. By inhibiting IL-23, TREMFYA® aims to manage the inflammatory response effectively.

The approval was grounded in compelling clinical data from multiple Phase 3 trials, including the GRAVITI study involving over 1,300 patients who either experienced an inadequate response or were intolerant to conventional therapies. Results indicated that TREMFYA® showed remarkable efficacy in achieving clinical and endoscopic endpoints, outperforming STELARA®—another existing treatment—in several key measures.

Key Clinical Results

In the GRAVITI trial, a regimen of 400 mg SC induction contrasted with placebo demonstrated:

• - Clinical Remission: 56% compared to placebo at 22%
• - Endoscopic Response: 34% against 15%

These results extend to long-term effectiveness, with continued improvement observed at the 48-week mark. The flexibility of administering TREMFYA® through SC injections or IV infusions offers healthcare providers and patients a tailored approach in managing their condition, which is particularly important as patient needs can vary.

Dr. Remo Panaccione, a prominent gastroenterology expert, emphasized the significance of this approval. He stated, 'Despite advancements in treating Crohn's disease, many patients still battle severe symptoms needing additional treatment avenues. The introduction of TREMFYA® provides an innovative IL-23 inhibitor with high endoscopic remission rates.'

Induction and Maintenance Treatment Regimen

TREMFYA® can be administered through:

• - Subcutaneous Induction: 400 mg given through two injections at Weeks 0, 4, and 8.
• - Intravenous Induction: 200 mg through IV infusions at the same intervals.
• - Maintenance Dosage: Following induction, maintenance therapy can include 100 mg SC every 8 weeks following Week 16, or 200 mg SC every 4 weeks starting at Week 12, based on clinical response.

These flexible treatment options allow healthcare providers the ability to address the unique needs of each patient while maintaining their therapeutic response effectively.

Commitment to Patient Support

Beyond the medication, Johnson & Johnson is committed to enhancing patient access to TREMFYA® through its support program, TREMFYA® withMe, designed to expedite treatment initiation. Eligible patients may receive their first induction treatment within as little as 24 hours of prescription.

This recent approval marks the fourth indication for TREMFYA® in the U.S., and follows prior approvals for plaque psoriasis, active psoriatic arthritis, and ulcerative colitis. Johnson & Johnson remains dedicated to continuing innovation in treatments for chronic immune-mediated conditions, such as inflammatory bowel disease.

Conclusion

The approval of TREMFYA® as a novel treatment choice for Crohn's disease represents a significant step forward in giving patients and healthcare providers more options in disease management. With its unique mechanism and clinical evidence supporting its effectiveness, TREMFYA® is poised to transform the treatment landscape for those affected by this challenging condition.