Johnson & Johnson Receives FDA Approval for Subcutaneous Tremfya Induction in Adults with Ulcerative Colitis.

Johnson & Johnson announced FDA approval for Tremfya's subcutaneous induction in adults with ulcerative colitis. Tremfya is a treatment for ulcerative colitis and Crohn's disease. The approval allows for a new treatment option for patients with moderate to severe ulcerative colitis. Johnson & Johnson's net sales include pharmaceutical products (64.1%) and medical products and equipment (35.9%). The company has 64 manufacturing facilities worldwide, with the United States accounting for 56.6% of net sales.

Johnson & Johnson (NYSE: JNJ) has received U.S. Food and Drug Administration (FDA) approval for a subcutaneous (SC) induction regimen of TREMFYA® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC). This approval marks a significant milestone, as it is the first and only IL-23 inhibitor to offer both SC and intravenous (IV) induction options for the treatment of UC and Crohn’s disease (CD), affecting approximately three million Americans TREMFYA® (guselkumab) achieves U.S. approval for ...^[1].

TREMFYA® is a fully-human, dual-acting monoclonal antibody that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23. IL-23 is a cytokine known to drive immune-mediated diseases including UC. The approval is based on results from the Phase 3 ASTRO trial, which demonstrated statistically significant and clinically meaningful improvements with TREMFYA® compared to placebo across all clinical and endoscopic measures TREMFYA® (guselkumab) achieves U.S. approval for ...^[1].

The recommended SC induction dosage is 400 mg (given as two consecutive injections of 200 mg each, dispensed in one Induction Pack) at Weeks 0, 4, and 8. The efficacy of SC and IV induction was comparable across subgroups with severe or refractory disease. The approval is a testament to Johnson & Johnson's commitment to advancing the clinical evidence of TREMFYA® in IBD TREMFYA® (guselkumab) achieves U.S. approval for ...^[1].

The company's net sales include pharmaceutical products (64.1%) and medical products and equipment (35.9%). With this approval, Johnson & Johnson continues its innovation in the treatment of chronic immune-mediated diseases, including inflammatory bowel disease. The company operates 64 manufacturing facilities worldwide, with the United States accounting for 56.6% of net sales TREMFYA® (guselkumab) achieves U.S. approval for ...^[1].