FDA Approves TREMFYA® as First IL-23 Inhibitor for Moderate to Severe Crohn's Disease

In a significant development for the treatment of Crohn's disease, the U.S. Food and Drug Administration (FDA) has recently approved TREMFYA® (guselkumab), an IL-23 inhibitor, marking a first in offering both subcutaneous (SC) and intravenous (IV) induction options for adults with moderate to severe Crohn's disease. This chronic inflammatory condition impacts the gastrointestinal tract and affects millions of individuals in the United States, underscoring the importance of new therapeutic options.

This approval extends the utility of TREMFYA®, which was previously approved for ulcerative colitis (UC), another major form of inflammatory bowel disease affecting around three million Americans. TREMFYA® is unique as it is the only dual-acting monoclonal antibody that not only blocks IL-23 but also binds to CD64, a receptor involved in the production of IL-23. This cytokine is known to play a significant role in autoimmune diseases, including Crohn's disease.

Dr. Remo Panaccione, a leading expert in inflammatory bowel disease and a key figure in the Phase 3 GRAVITI study, emphasized the need for new treatments, highlighting that many Crohn's disease patients continue to suffer from severe symptoms despite the availability of existing therapies. The introduction of TREMFYA®, with its innovative IL-23 inhibitor mechanism, promises improved patient outcomes, offering both SC and IV induction regimens. This flexibility allows for personalized treatment plans, potentially enhancing patient adherence and satisfaction.

The FDA's approval is grounded in comprehensive Phase 3 trials involving over 1,300 patients with moderate to severe Crohn's disease who had not responded well to traditional therapies or biologics. The GRAVITI trial assessed the efficacy of TREMFYA® SC induction and maintenance therapy against placebo, while the GALAXI clinical program demonstrated TREMFYA®'s superiority over STELARA® in all pooled endoscopic endpoints. These trials collectively showcased the robust efficacy of TREMFYA®, achieving significant clinical and endoscopic outcomes.

The clinical data reveal impressive results, with notable improvements in clinical remission and endoscopic response rates as early as week 12, which were maintained through week 48 of the trials. For instance, at week 12, 56% of patients in the GRAVITI study achieved clinical remission compared to 22% in the placebo group, a statistically significant outcome. Endoscopic responses were also marked, with TREMFYA® demonstrating substantial superiority over STELARA® in all assessed endpoints.

Dr. Chris Gasink, Vice President of Medical Affairs at Johnson & Johnson, expressed optimism about TREMFYA®'s potential, noting its unique status as the first IL-23 inhibitor offering a fully subcutaneous induction regimen for Crohn's disease. This advancement allows patients to begin treatment with the convenience of self-administration, aligning with contemporary trends in patient-centered healthcare.

The dosing regimen for TREMFYA® involves an initial SC induction dosage of 400 mg, administered through two consecutive 200 mg injections at specified intervals, with maintenance dosages adjusted to sustain therapeutic response. For patients requiring IV induction, a 200 mg dosage is given at specified weeks, followed by SC maintenance. Healthcare providers are advised to administer the lowest effective dose to maintain efficacy.

Johnson & Johnson is committed to facilitating access to TREMFYA® through its TREMFYA® withMe program, which supports insured patients in initiating treatment promptly. This approval marks the fourth indication for TREMFYA® in the United States, reflecting Johnson & Johnson's enduring commitment to innovation and improving the lives of those with chronic immune-mediated diseases.

TREMFYA®'s approval history includes moderate-to-severe plaque psoriasis and active psoriatic arthritis, with its latest indication reinforcing its role in addressing complex inflammatory conditions. The approval is a testament to ongoing advancements in medical science, offering renewed hope to patients and healthcare providers battling Crohn's disease.