STORY
The Medicines and Healthcare products Regulatory Agency (MHRA) has today approved guselkumab (Tremfya) to treat adults with moderately to severely active Crohn’s disease and ulcerative colitis (UC) who have failed other therapies or cannot tolerate them.
Previously authorised for plaque psoriasis and psoriatic arthritis, guselkumab is the first IL-23 inhibitor in the UK licensed for inflammatory bowel disease. It can be given by intravenous infusion or subcutaneous injection for Crohn’s disease, and by infusion for the initial treatment of UC.
Clinical trials underpinning the approval included:
Crohn’s disease: Up to 56% of patients on guselkumab achieved clinical remission at 12 weeks, versus 15–22% on placebo. Endoscopic response—indicating reduced intestinal inflammation—was observed in up to 41% of treated patients compared to 11–21% with placebo.
Ulcerative colitis: After 12 weeks of induction therapy, 23% of guselkumab-treated patients reached clinical remission, compared to 8% on placebo. Maintenance dosing saw remission rates climb to 50% at 44 weeks versus 19% for placebo.
Julian Beach, MHRA Interim Executive Director of Healthcare Quality and Access, said:
“Patient safety is our top priority, which is why I am pleased to confirm the approval of guselkumab to treat Crohn’s disease and ulcerative colitis. We’re assured that the appropriate regulatory standards of safety, quality and efficacy for the approval of this new formulation have been met. As with all products, we will keep its safety under close review.”