MHRA approves guselkumab for Crohn바카라 사이트檚 disease and ulcerative colitis
As with all products, we will keep its safety under close review
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 16 May 2025, approved guselkumab (Tremfya) to treat Crohn바카라 사이트檚 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 Crohn바카라 사이트檚 disease and UC who have not responded well to other treatments or experienced unacceptable side effects.
Using guselkumab in Crohn바카라 사이트檚 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 patient바카라 사이트檚 ability to do normal daily activities and reduce fatigue.
Guselkumab can be administered either by intravenous infusion or injection for the initial treatment of Crohn바카라 사이트檚 disease. For UC, initial treatment will be administered via an intravenous infusion.
Julian Beach, MHRA Interim Executive Director of Healthcare Quality and Access, said:바카라 사이트�
바카라 사이트淧atient safety is our top priority, which is why I am pleased to confirm the approval of guselkumab to treat Crohn바카라 사이트檚 disease and ulcerative colitis.
바카라 사이트淲e바카라 사이트檙e assured that the appropriate regulatory standards of safety, quality and efficacy for the approval of this new formulation have been met.
바카라 사이트淎s with all products, we will keep its safety under close review.바카라 사이트�바카라 사이트犅�
In Crohn바카라 사이트檚 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 15바카라 사이트�22% with placebo. Endoscopic response, indicating reduced inflammation in the intestines, was seen in up to 41% of guselkumab-treated patients, compared to 11바카라 사이트�21% receiving placebo.聽
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.바카라 사이트�
As with any medicine, the MHRA will keep the safety and effectiveness of guselkumab under close review.바카라 사이트� 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 () or by searching the Google Play or Apple App stores for MHRA Yellow Card.바카라 사이트�바카라 사이트�
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Notes to editors바카라 사이트�바카라 사이트�바카라 사이트�바카라 사이트�
- The approval was granted on 16 May 2025 to Janssen-Cilag Limited.
- This product was submitted and approved via national procedure.
- More information can be found in the Summary of Product Characteristics and Patient Information leaflets which will be published on the 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.바카라 사이트� 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.
Updates to this page
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Removal of bullet point in 'Notes to editors' which outlines clinical trial information. This is already covered in the main text.
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First published.