Words by Isabel O’Brien
Johnson & Johnson have secured EU Marketing Authorisation for their drug to treat moderate-to-severe ulcerative colitis (UC), offering a new treatment option for patients who have not responded adequately to previous therapies. UC is a chronic condition that causes inflammation of the colon lining, leading to persistent symptoms, such as abdominal pain, diarrhoea, fatigue and unintended weight loss.
Based on results from two key studies, guselkumab showed superiority over placebo in the Phase 2b trial, with 53% of patients achieving clinical remission compared to 27% in the placebo group. A Phase 3 maintenance study showed a 45% improvement in colon mucosal healing, reinforcing the drug’s potential.
“Treatment with guselkumab led to significant improvement in the chronic symptoms of ulcerative colitis,” affirmed Dr Laurent Peyrin-Biroulet, Head of the Inflammatory Bowel Disease (IBD) Unit, Nancy University Hospital, France, and study investigator. “This approval represents a significant advancement in managing this chronic inflammatory disease.”
Guselkumab is the first approved UC treatment to target IL-23 in two distinct ways, offering a new approach compared to existing therapies, which don’t currently provide all patients with respite or remission. Despite advances over the past two decades, research shows that only 20–30% of patients achieve remission after initial treatment, and fewer than half of those maintain it over time.
“There is significant need for new UC therapies that offer meaningful improvements in symptoms and the promise of remission,” said Mark Graham, Senior Director, Therapeutic Area Lead, Immunology, J&J Innovative Medicine, EMEA. “This approval builds on our sustained efforts to help improve the quality of life of patients, which can be significantly impacted from both a physical and mental health perspective.”
This isn’t the first indication approval for guselkumab. The drug was previously approved in the EU for moderate-to-severe plaque psoriasis in 2017 and psoriatic arthritis in 2020. Just last month, it received a regulatory nod for Crohn’s disease in the US.
