Johnson & Johnson seeks USFDA nod for Tremfya for ulcerative colitis treatment in adults
Spring House: Johnson & Johnson has announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of TREMFYA (guselkumab) for treatment of adults with moderately to severely active ulcerative colitis (UC).
The submission is based on results from the Phase 3 QUASAR program evaluating the efficacy and safety of TREMFYA in the treatment of individuals living with moderately to severely active UC who had an inadequate response or intolerance to conventional therapy, prior biologics and/or JAK inhibitors. The data show statistically significant and clinically meaningful improvements in symptoms, patient-reported outcomes such as fatigue and measures of disease activity including high bar endpoints such as endoscopic and histologic remission. The safety results were consistent with the known safety profile of TREMFYA in approved indications.
"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. "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."
Clinical data from the Phase 3 QUASAR induction study through 12 weeks were presented at the 2023 Digestive Disease Week (DDW) Annual Meeting and results from the Phase 3 QUASAR maintenance study through 44 weeks will be presented at an upcoming medical meeting.
TREMFYA is a dual-acting IL-23i that blocks IL-23 and binds to CD64, a receptor on cells that produce IL-23.4 IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases including UC. TREMFYA was first approved in the U.S. in July 2017 for the treatment of adult patients with moderate-to-severe plaque psoriasis and was subsequently also approved for adults with active psoriatic arthritis in July, 2020.
TREMFYA is also approved in Canada, Japan and a number of other countries for the treatment of adults with moderate to severe plaque psoriasis (PsO) who are candidates for injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light) and for the treatment of adult patients with active psoriatic arthritis ( PsA). It is also approved in the EU for the treatment of moderate to severe plaque PsO in adults who are candidates for systemic therapy and for the treatment of active PsA in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug therapy. Johnson & Johnson maintains exclusive worldwide marketing rights to TREMFYA.
Ulcerative colitis (UC) is a chronic disease of the large intestine, also known as the colon, in which the lining of the colon becomes inflamed and develops tiny open sores, or ulcers, that produce pus and mucus. It is the result of the immune system's overactive response. Symptoms vary, but may include loose and more urgent bowel movements, rectal bleeding or bloody stool, persistent diarrhea, abdominal pain, loss of appetite, weight loss and fatigue.
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