US-based pharmaceutical company Johnson & Johnson (J&J) has received the US Food and Drug Administration (FDA) expanded approval for Tremfya (guselkumab) to include ulcerative colitis (UC).
Tremfya is a dual-acting monoclonal antibody designed to neutralise inflammation at the cellular source by blocking IL-23 and binding to CD64, a receptor on cells that produce IL-23.
IL-23 is a cytokine secreted by activated monocytes and dendritic cells and is known to be a driver of immune-mediated diseases, including UC.
Tremfya was initially approved in the US in 2017 to treat moderate-to-severe plaque psoriasis and an expanded approval in 2020 to include active psoriatic arthritis in adults.
The current, third indication includes adults with moderately to severely active UC, a chronic disease of the large intestine characterised by inflammation of the lining of the colon.
Earlier this year, J&J submitted a supplemental Biologics License Application (sBLA) for Tremfya, seeking FDA approval to treat moderately to severely active Crohn’s disease (CD).
Johnson & Johnson Innovative Medicine gastroenterology and autoantibody medical affairs vice president Christopher Gasink said: “There is a significant need for new UC therapies that offer meaningful improvements in symptoms and the promise of remission, both overall clinical remission as well as delivering visible healing of the colon through endoscopic remission.
“In the Quasar clinical programme, Tremfya demonstrated high reported rates of endoscopic remission at one year of treatment, continuing to raise the bar for efficacy in the treatment of this inflammatory bowel disease.”
The FDA approval is supported by data from the ongoing Phase 2b/3 Quasar study evaluating the efficacy and safety of Tremfya in adults previously treated for UC.
Phase 2b/3 included a Phase 2b dose-ranging induction study, a confirmatory Phase 3 induction study, and a Phase 3 maintenance study.
In the study, 50% of patients receiving Tremfya 200mg every four weeks and 45% of patients receiving Tremfya 100mg every eight weeks achieved the primary endpoint of clinical remission at week 44 compared to 19% of patients treated with placebo.
Also, 34% of patients receiving 200mg and 35% of patients receiving 100mg Tremfya achieved endoscopic remission at one year, compared to 15% of patients treated with placebo.
J&J said that the results from the Quasar study strengthened the well-established safety profile of Tremfya including in the treatment of patients with UC.
Quasar programme lead investigator David Rubin said: “Treatment with Tremfya resulted in significant improvement in the chronic symptoms of ulcerative colitis, and importantly, normalization in the endoscopic appearance of the intestinal lining.
“Today’s approval of Tremfya builds on the clinical and well-established safety profile of this IL-23 inhibitor and marks a significant step forward in the treatment of this chronic inflammatory disease.”
