MHRA approves guselkumab for Crohn’s disease and ulcerative colitis

Regulator confirms safety and efficacy of new treatment option for patient

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved guselkumab (Tremfya) for the treatment of Crohn’s disease and ulcerative colitis (UC).

Already used for plaque psoriasis and psoriatic arthritis, guselkumab has shown efficacy in adults with moderately to severely active Crohn’s disease and UC who have not responded to other treatments or experienced unacceptable side effects.

Guselkumab helps to reduce symptoms associated with Crohn’s disease, including diarrhoea and abdominal pain. In UC, it alleviates intestinal inflammation and discomfort, improving patients’ ability to carry out daily activities and reducing fatigue.

For Crohn’s disease, guselkumab is initially administered either by intravenous infusion or injection. For UC, initial treatment is given via 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.”

Clinical studies involving around 1,400 Crohn’s disease patients showed that up to 56% achieved remission after 12 weeks of guselkumab treatment, compared to 15–22% receiving placebo. Endoscopic response was observed in up to 41%, compared to 11–21% in the placebo group.

In UC trials, 23% of patients receiving guselkumab achieved remission after 12 weeks, compared to 8% with placebo. Continued treatment led to remission in up to 50% after 44 weeks, versus 19% with placebo.

Side effects are listed in the Patient Information Leaflet (PIL) and the Summary of Product Characteristics (SmPC), available on the MHRA website within seven days of approval.