Johnson & Johnson has announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval for a subcutaneous (SC) induction regimen of Tremfya (guselkumab) for the treatment of adults living with moderately to severely active ulcerative colitis (UC). This submission is supported by data from the Phase 3 ASTRO study, which evaluated Tremfya SC induction therapy in adults with UC.
The sBLA builds upon the recent U.S. approval of Tremfya for UC, potentially offering a new administration route for induction therapy. Ulcerative colitis, a chronic inflammatory bowel disease, affects millions worldwide, causing significant morbidity and impacting quality of life. Current treatment options often involve intravenous infusions or other systemic therapies, which can be burdensome for patients.
The Phase 3 ASTRO study evaluated the efficacy and safety of Tremfya SC induction therapy in adult patients with moderately to severely active UC. The study's results demonstrated clinically meaningful improvements in disease activity and patient-reported outcomes. The subcutaneous formulation offers a more convenient administration option, potentially improving patient adherence and overall treatment experience.
"The submission of this sBLA marks an important step forward in our commitment to providing innovative treatment options for individuals living with ulcerative colitis," said a representative from Johnson & Johnson. "We are confident that the subcutaneous induction regimen of Tremfya has the potential to address the unmet needs of patients and improve their overall well-being."
The FDA will now review the sBLA, and a decision is expected in the coming months. If approved, the subcutaneous induction regimen of Tremfya would provide a valuable new option for managing ulcerative colitis, offering patients a more convenient and potentially more accessible treatment approach.
