Janssen-Cilag International, a Johnson & Johnson company, has submitted applications to the European Medicines Agency (EMA) seeking to expand the marketing authorisation application for Tremfya (guselkumab) to include the treatment of adult patients with moderately to severely active ulcerative colitis and moderately to severely active Crohn’s disease.
The submission included data from the Phase III QUASAR programme in ulcerative colitis and the Phase III GALAXI programme in Crohn’s disease.1,2,3,4,5
QUASAR
In the Phase III QUASAR induction and maintenance studies, guselkumab achieved each primary endpoint and showed statistically significant and clinically meaningful improvements relative to placebo in symptoms, measures of disease activity including stringent endpoints such as endoscopic normalisation and histo-endoscopic mucosal healing and patient-reported outcomes such as fatigue.1,3,4
The safety results were consistent with the known safety profile of Tremfya in approved indications.3,4a
GALAXI
In the Phase III GALAXI 2 and 3 programme, guselkumab achieved co-primary endpoints demonstrating statistically significant and clinically meaningful improvements relative to placebo in clinical remission and endoscopic response.2,5
Safety results were consistent with the known safety profile of Tremfya in approved indications.2,5
Guselkumab is the first approved fully-human monoclonal antibody that blocks IL-23 by binding to the p19 subunit of IL-23.6 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 ulcerative colitis and Crohn’s disease.7
Guselkumab's EU approval status
Guselkumab is approved in the European Union (EU) for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy and for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug therapy.6
“People living with chronic, immune-mediated disease such as ulcerative colitis and Crohn’s disease often spend a considerable amount of time cycling from one treatment to another in search of relief and sustained remission,” said David Lee, MD, PhD, Global Therapeutic Area Head Immunology, Johnson & Johnson Innovative Medicine. “This submission is an important step in our mission to develop novel, effective therapies for the millions of people worldwide living with ulcerative colitis and Crohn’s disease who are experiencing persistent and debilitating symptoms.”
Clinical data from the Phase III QUASAR induction study through 12 weeks were presented at the 2023 Digestive Disease Week Annual Meeting and results from the Phase III QUASAR maintenance study through 44 weeks will be presented at an upcoming medical meeting.3
Clinical data from the long-term extension of the GALAXI Phase II study through three years were presented at United European Gastroenterology Week 2023 and results from the GALAXI Phase III studies through 48 weeks will be presented at an upcoming medical meeting.5
In March 2024, Johnson & Johnson submitted a supplemental Biologics License Application to the US Food and Drug Administration seeking approval of guselkumab for treatment of adults with moderately to severely active ulcerative colitis.
References
1 https://www.clinicaltrialsregister.eu/ctr-search/trial/2018-004002-25/SE/.
2 https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-002195-13/ES.
3 Allegretti, J, et al. The efficacy and safety of guselkumab induction therapy in patients with moderately to severely active ulcerative colitis: Results from the Phase 3 QUASAR induction study. Presented at Digestive Disease Week, May 6-9
4 https://pubmed.ncbi.nlm.nih.gov/37659673/
5 Afzali, A, et al. Efficacy and safety of guselkumab for Crohn’s disease through 3 years: GALAXI-1 Long-Term extension. Presented at United European Gastroenterology Week 2023, October 14-17.
6 https://www.ema.europa.eu/en/documents/product-information/tremfya-epar-product-information_en.pdf.