FDA Approves Subcutaneous Tremfya for Induction Treatment of Ulcerative Colitis

The U.S. Food and Drug Administration (FDA) has granted approval for a new subcutaneous (SC) induction regimen of Tremfya (guselkumab) to treat adults suffering from moderately to severely active ulcerative colitis. This marks a significant advancement in the management of the condition, providing a more convenient and accessible treatment option.

Tremfya, developed by Johnson & Johnson, is renowned as the first and only interleukin-23 (IL-23) inhibitor to offer both subcutaneous and intravenous (IV) induction options for ulcerative colitis and Crohn's disease. Traditionally, IL-23 inhibitors required IV infusions at the start of therapy, which could pose logistical challenges for patients and healthcare providers. The new subcutaneous regimen simplifies administration, allowing patients to self-inject without compromising efficacy or safety.

The approval is supported by data from the Phase III ASTRO trial. The study demonstrated that, within just two weeks, patients receiving Tremfya experienced significant symptom improvement compared to placebo, with early response rates sustained through 24 weeks. Specifically, at 12 weeks, 26% of patients treated with Tremfya (400 mg every four weeks) achieved clinical remission, compared to only 7% with placebo. Additionally, 36% showed endoscopic improvement versus 12% with placebo. These results align with previous findings observed with the FDA-approved IV regimen.

Dr. David T. Rubin, a leading researcher from the University of Chicago, emphasized that the availability of a self-injectable option could reduce barriers to starting treatment and improve patient adherence. “Patients and providers now have the choice to begin therapy with a subcutaneous injection, maintaining the same high standards of safety and effectiveness established in clinical trials,” he stated.

This milestone expands therapeutic options for ulcerative colitis, potentially improving quality of life for many patients by simplifying treatment regimens. For more detailed information, visit Johnson & Johnson’s official announcement.