HORSHAM, PA — Johnson & Johnson (NYSE: JNJ) has announced the FDA‘s approval of TREMFYA® (guselkumab) for adults with moderately to severely active ulcerative colitis (UC). This chronic inflammatory condition affects the large intestine, causing significant discomfort and health issues. TREMFYA® distinguishes itself as the first fully-human, dual-acting monoclonal antibody to receive approval for UC, targeting both IL-23 and the CD64 receptor on cells producing IL-23, a cytokine linked to immune-mediated diseases.
Dr. David T. Rubin, Director of the Inflammatory Bowel Disease Center at the University of Chicago Medicine and lead investigator for the QUASAR program, noted the drug’s efficacy: “Treatment with TREMFYA resulted in significant improvement in the chronic symptoms of ulcerative colitis, and importantly, normalization in the endoscopic appearance of the intestinal lining.” This approval highlights TREMFYA’s robust safety and efficacy profile, offering a significant advancement for UC treatment.
The approval follows results from the pivotal Phase 2b/3 QUASAR study, which evaluated TREMFYA® in patients unresponsive to conventional therapies, biologics, or JAK inhibitors. The study revealed that 50% of patients on a 200 mg dose every four weeks and 45% on a 100 mg dose every eight weeks achieved clinical remission by week 44, compared to only 19% of those on a placebo. Furthermore, a notable percentage of patients attained endoscopic remission, emphasizing the drug’s potential to visibly heal the colon.
Dr. Christopher Gasink, Vice President of Medical Affairs in Gastroenterology & Autoantibody at Johnson & Johnson Innovative Medicine, remarked, “There is a significant need for new UC therapies that offer meaningful improvements in symptoms and the promise of remission, both overall clinical remission as well as delivering visible healing of the colon through endoscopic remission.”
TREMFYA® is administered via a 200 mg induction dose intravenously at weeks zero, four, and eight, with maintenance doses varying between 100 mg every eight weeks or 200 mg every four weeks following induction. Patients can self-administer these doses after receiving proper training.
This new indication for TREMFYA® builds on its established track record, initially approved in 2017 for plaque psoriasis and later for psoriatic arthritis. With an ongoing application for Crohn’s disease treatment, Johnson & Johnson continues to expand its impact in the field of immunology, reinforcing its commitment to innovation in managing chronic inflammatory diseases.
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