The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 16 May 2025, approved guselkumab (Tremfya) to treat Crohn’s disease and ulcerative colitis (UC).
Guselkumab is currently approved to treat plaque psoriasis and psoriatic arthritis. However, clinical studies have shown that guselkumab is also efficacious in treating adults with moderately to severely active Crohn’s disease and UC who have not responded well to other treatments or experienced unacceptable side effects.
Using guselkumab in Crohn’s disease can benefit patients by reducing the signs and symptoms of the disease, which can include diarrhoea and abdominal pain. In UC it helps to reduce abdominal pain and inflammation of the intestinal lining. These effects can improve a patient’s ability to do normal daily activities and reduce fatigue.
Guselkumab can be administered either by intravenous infusion or injection for the initial treatment of Crohn’s disease. For UC, initial treatment will be administered via an intravenous infusion.
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.”
In Crohn’s disease, three major studies involving around 1,400 patients found that up to 56% of those treated with guselkumab achieved clinical remission after 12 weeks, compared to 15–22% with placebo. Endoscopic response, indicating reduced inflammation in the intestines, was seen in up to 41% of guselkumab-treated patients, compared to 11–21% receiving placebo.
In a clinical study for UC, 23% of patients receiving guselkumab achieved clinical remission after 12 weeks of induction treatment, compared to 8% on placebo. Continued maintenance treatment led to remission in up to 50% of patients after 44 weeks, versus 19% with placebo.
A full list of side effects can be found in the Patient Information Leaflet (PIL) or the Summary of Product Characteristics (SmPC), available on the MHRA website within 7 days of approval.
As with any medicine, the MHRA will keep the safety and effectiveness of guselkumab under close review. Anyone who suspects they are having a side effect from this medicine is encouraged to talk to their doctor, pharmacist or nurse and report it directly to the MHRA Yellow Card scheme, either through the website (https://yellowcard.mhra.gov.uk/) or by searching the Google Play or Apple App stores for MHRA Yellow Card.
ENDS
Notes to editors
- The approval was granted on 16 May 2025 to Janssen-Cilag Limited.
- This product was submitted and approved via national procedure.
- A randomised, open-label Phase 3 clinical trial is a large, late-stage study where participants are randomly assigned to different treatment groups, both doctors and patients know which treatment is being given (open-label), and the goal is to confirm the treatment’s effectiveness and safety before potential regulatory approval.
- More information can be found in the Summary of Product Characteristics and Patient Information leaflets which will be published on the MHRA Products website within 7 days of approval.
- The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
- The MHRA is an executive agency of the Department of Health and Social Care.
- For media enquiries, please contact the newscentre@mhra.gov.uk, or call on 020 3080 7651.
