HORSHAM, PA — Johnson & Johnson (NYSE: JNJ) has announced that the U.S. Food and Drug Administration (FDA) has approved TREMFYA® (guselkumab) for the treatment of adults with moderately to severely active Crohn’s disease (CD). This approval marks a significant milestone as TREMFYA becomes the first and only interleukin-23 (IL-23) inhibitor available with both subcutaneous (SC) and intravenous (IV) induction options.
The approval of TREMFYA is supported by robust data from multiple Phase 3 trials, which evaluated more than 1,300 patients with CD who were intolerant or unresponsive to conventional therapies or biologics. Data revealed that TREMFYA delivered significant improvements in clinical and endoscopic outcomes, with results from the GRAVITI and GALAXI trials showing superiority over STELARA® in key endoscopic endpoints.
“Despite the progress in the management of Crohn’s disease, many patients experience debilitating symptoms and are in need of new treatment options,” said Dr. Remo Panaccione, Professor of Medicine at the University of Calgary and lead investigator of the GRAVITI study. “The approval of TREMFYA offers an IL-23 inhibitor that has shown robust rates of endoscopic remission with both subcutaneous and intravenous induction regimens. Importantly, the fully subcutaneous regimen offers choice and flexibility for patients and providers that have not been available before.”
TREMFYA, a fully-human monoclonal antibody, is distinct in its mechanism of action by targeting IL-23 and binding to CD64, a receptor on cells producing IL-23, a cytokine implicated in immune-mediated diseases like CD. The flexibility in administration options enhances its appeal, allowing patients and healthcare providers to tailor the route of treatment.
“TREMFYA is the first and only IL-23 inhibitor that offers a fully subcutaneous treatment option for moderately to severely active Crohn’s disease. With the approval of TREMFYA, it is now possible to achieve meaningful improvements in clinical and endoscopic outcomes with the flexibility of self-administration from the start,” said Dr. Chris Gasink, Vice President of Medical Affairs for Gastroenterology & Autoantibody at Johnson & Johnson Innovative Medicine.
The recommended dose for SC induction is 400 mg administered at Weeks 0, 4, and 8, followed by maintenance dosing of 100 mg every 8 weeks or 200 mg every 4 weeks as needed. An IV induction option is also available at the same intervals, providing healthcare providers greater flexibility in treatment planning.
This FDA approval marks the fourth indication for TREMFYA in the U.S., solidifying Johnson & Johnson’s position as a leader in innovation for chronic immune-mediated diseases. With this launch, the company also offers support through its TREMFYA® withMe program to improve accessibility for eligible patients.
TREMFYA’s success in addressing significant unmet needs in Crohn’s disease represents a pivotal advancement, aligning with Johnson & Johnson’s commitment to improving outcomes for patients living with complex immune-related conditions.
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