A dual-acting IL-23 inhibitor, TREMFYA acts on both IL-23 and CD64 to potentially provide relief for patients.
The sBLA is based on the data from the Phase III QUASAR programme, which assessed the safety and efficacy of TREMFYA in UC patients who had not adequately responded to standard therapy, previous treatment with biologics or JAK inhibitors.
The randomised, double-blind, placebo-controlled, parallel group, multicentre, seamless QUASAR programme comprised Phase 2b dose-ranging induction, confirmatory Phase III induction and a Phase III maintenance trials.
Results from the QUASAR programme showed that TREMFYA led to statistically significant and clinically meaningful improvements in UC symptoms. These improvements comprised reductions in fatigue and other disease activity measures.
Notably, the treatment achieved high bar endpoints like endoscopic and histologic remission.
The safety profile observed in the UC studies was in line with already reported safety data of TREMFYA in its prior approved indications.
TREMFYA initially received approval in the US in July 2017 to treat adults with moderate-to-severe plaque psoriasis.
In July 2020, the FDA expanded its indication for the treatment of adults with active psoriatic arthritis.
Johnson & Johnson Immunology global therapeutic area head David Lee said: “Despite advances in therapy, many people living with ulcerative colitis still experience inadequate response to or do not tolerate existing therapies.
“TREMFYA has the potential to be a new treatment option for patients. We look forward to working with the FDA in review of this application and remain focused on developing new therapies for those living with chronic autoimmune conditions, such as ulcerative colitis, who are experiencing persistent and debilitating symptoms.”