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.
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.
