Johnson & Johnson Submits sBLA for Approval of Guselkumab for Adults with Ulcerative Colitis

Johnson & Johnson recently announced the submission of a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for approval of guselkumab (Tremfya®) for the treatment of moderate-to-severe active ulcerative colitis (UC) in adults.

Guselkumab is a novel fully human immunoglobulin G1 lambda monoclonal antibody (mAb) that blocks human interleukin (IL)-23 by binding to the p19 subunit of IL-23 and binds to CD64, a receptor on cells that produce IL-23, according to the company’s March 11, 2024, press release.

In July 2017, guselkumab was first approved in the US for the treatment of adults with moderate-to-severe plaque psoriasis and was then also approved for adults with active psoriatic arthritis in July 2020, according to Johnson & Johnson.

Johnson & Johnson submitted the sBLA based on results from the phase III QUASAR program, which was designed to evaluate the efficacy and safety of guselkumab in adults with moderate-to-severe active UC who had an inadequate response or intolerance to traditional therapy (eg, corticosteroids, thiopurines), prior biologics, and/or JAK inhibitors.

Findings from the QUASAR induction study through 12 weeks were presented at the 2023 Digestive Disease Week Annual Meeting and showed statistically significant and clinically meaningful improvements in UC symptoms. Also, patient reported outcomes (eg, fatigue) and measures of disease activity including endpoints such as endoscopic and histologic remission; safety results were consistent with the known safety profile of guselkumab in approved indications, noted the manufacturer.

“Despite advances in therapy, many people living with ulcerative colitis still experience inadequate response to or do not tolerate existing therapies,” said David Lee, MD, PhD, global therapeutic area head immunology, Johnson & Johnson, in the press release. “TREMFYA has the potential to be a new treatment option for patients.”

Results from the QUASAR maintenance study through 44 weeks will be presented at an upcoming medical meeting, stated Johnson & Johnson.

Source: Johnson & Johnson submits supplemental Biologics License Application to U.S. FDA seeking approval of TREMFYA® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis. News release. Johnson & Johnson. March 11, 2024. Accessed March 21, 2024. https://www.jnj.com/media-center/press-releases/johnson-johnson-submits-supplemental-biologics-license-application-to-u-s-fda-seeking-approval-of-tremfya-guselkumab-for-the-treatment-of-adults-with-moderately-to-severely-active-ulcerative-colitis