A new subcutaneous (SC) induction regimen for Johnson & Johnson’s TREMFYA® (guselkumab) has been approved by the U.S. Food and Drug Administration (FDA) to treat individuals with moderately to severely active ulcerative colitis (UC). With its approval, TREMFYA becomes the first and only IL-23 inhibitor to provide a completely subcutaneous regimen for UC treatment, both for induction and maintenance.
The approval offers patients a new, practical, at-home therapy alternative, which is a major advancement. In the past, intravenous (IV) injection was necessary for TREMFYA induction for UC. Patients can now choose between intravenous and subcutaneous induction, both of which result in a subcutaneous maintenance regimen.
The Phase 3 ASTRO trial results, which showed the subcutaneous induction therapy’s effectiveness and safety, served as the foundation for the FDA’s conclusion. At Week 12, TREMFYA-treated patients demonstrated significantly higher rates of endoscopic improvement and clinical remission than placebo-treated patients. Remarkably, a favorable symptomatic reaction was noted as early as week two and persisted until week twenty-four. Additionally, the study discovered that even in patients with severe or challenging-to-treat conditions, the effectiveness of the intravenous and subcutaneous induction techniques was equivalent.
For TREMFYA, a subcutaneous induction dosage of 400 mg should be given at Weeks 0, 4, and 8. After induction, subcutaneous administration of 100 mg every 8 weeks or 200 mg every 4 weeks is advised for maintenance. Infusions of 200 mg are given to individuals who choose intravenous induction at Weeks 0, 4, and 8.
Read More: STELARA® (ustekinumab) for Pediatric Crohn’s Disease: Johnson & Johnson Files for FDA Approval
Side effects are possible with every drug. Joint pain, injection site responses, headaches, and respiratory tract infections are the most frequent adverse effects linked to TREMFYA. Liver issues, infections, and severe allergic reactions are examples of more serious side effects. Before starting TREMFYA treatment, patients should get checked for infections and tuberculosis (TB), and they should refrain from receiving live vaccines while undergoing treatment.
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TREMFYA has been licensed for Crohn’s disease as well, which further strengthens its status as a flexible therapy choice for inflammatory bowel illnesses. In order to compare TREMFYA with Skyrizi® (risankizumab) in the treatment of Crohn’s disease, Johnson & Johnson has also revealed plans for a head-to-head research.
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Graduated from the University of Kerala'20 with B.Sc. Botany & Biotechnology. Post-graduation in Biotechnology from the University of Kerala'22. Internship experience in Cancer Research.
