U.S. pharmaceutical giant Johnson & Johnson (J&J, NYSE: JNJ) presented positive results from the Phase III ASTRO study of its Tremfya (guselkumab) subcutaneous (SC) induction therapy for adults with moderately to severely active ulcerative colitis (UC) at the 20th Congress of the European Crohn’s and Colitis Organization (ECCO). The data supports the company’s pursuit of regulatory approvals for an expanded SC induction regimen.
Study Results
The ASTRO study met all primary and secondary endpoints. At Week 12, patients treated with Tremfya 400 mg SC induction showed significantly higher rates of clinical remission (27.6% vs. 6.5%; P<0.001), clinical response (65.6% vs. 34.5%; P<0.001), and endoscopic improvement (37.3% vs. 12.9%; P<0.001) compared to placebo. The safety profile of Tremfya was consistent with previous trials.
Regulatory and Therapeutic Context
Tremfya, the first monoclonal antibody (mAb) targeting IL-23 and CD64, is already approved in the U.S. for plaque psoriasis, psoriatic arthritis, and UC. In September 2024, the FDA approved Tremfya for UC via intravenous (IV) induction followed by SC maintenance. J&J submitted a supplemental Biologics License Application (sBLA) in November 2024 seeking approval for the SC induction regimen in UC. Additionally, an application for Tremfya’s use in moderately to severely active Crohn’s disease (CD) is under review.-Fineline Info & Tech
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