Johnson & Johnson Seeks FDA Approval for TREMFYA® in Ulcerative Colitis Treatment

Published March. 15. 2024

Johnson & Johnson has made a significant stride in the field of autoimmune disease treatment with its latest submission to the U.S. Food and Drug Administration (FDA). The pharmaceutical giant has applied for approval of TREMFYA® (guselkumab) to treat adults grappling with moderately to severely active ulcerative colitis (UC). This milestone follows the Phase 3 QUASAR program’s promising results, which evaluated TREMFYA®’s efficacy and safety in patients who had an inadequate response or intolerance to conventional therapy, previous biologics, and/or JAK inhibitors. The data from the program revealed statistically significant improvements in symptoms and patient-reported outcomes, alongside notable advancements in measures of disease activity, including endoscopic and histologic remission. Moreover, the safety profile of TREMFYA® in this indication remained consistent with its established safety record in approved uses. 

Dr. David Lee, Global Therapeutic Area Head Immunology at Johnson & Johnson, emphasized the pressing need for new therapeutic options in managing ulcerative colitis. Despite medical advancements, many patients continue to grapple with inadequate responses to existing treatments or face intolerable side effects. Dr. Lee highlighted TREMFYA®’s potential to address this unmet medical need and expressed the company’s commitment to developing innovative therapies for individuals living with chronic autoimmune conditions. 

TREMFYA® stands out as a dual-acting IL-23 inhibitor, targeting IL-23 and binding to CD64 receptors on IL-23-producing cells. IL-23, a cytokine linked to immune-mediated diseases like UC, plays a pivotal role in disease pathology. First approved in the U.S. in 2017 for moderate-to-severe plaque psoriasis and later for active psoriatic arthritis in 2020, TREMFYA® has demonstrated its versatility in treating various autoimmune conditions. 

Clinical findings from the Phase 3 QUASAR induction study, presented at the 2023 Digestive Disease Week (DDW) Annual Meeting, offer promising insights into TREMFYA®’s efficacy. The upcoming presentation of results from the Phase 3 QUASAR maintenance study through 44 weeks underscores the ongoing commitment to advancing the understanding and treatment of ulcerative colitis. Johnson & Johnson’s submission of the supplemental Biologics License Application (sBLA) marks a significant step forward in providing patients with a potential new therapeutic option, pending FDA review and approval. 

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