Johnson & Johnson (J&J) has received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) for its dual-acting IL-23 inhibitor Tremfya (guselkumab) in Crohn’s disease (CD) and ulcerative colitis (UC).
CD and UC are the two main forms of inflammatory bowel disease (IBD), which affects more than 500,000 people in the UK. Patients can experience a range of symptoms, including diarrhoea, abdominal pain and bloody stools.
Tremfya is designed to block IL-23, an important driver of inflammatory diseases, and is already approved in the UK to treat certain cases of plaque psoriasis and psoriatic arthritis.
The MHRA’s approval of the drug in CD was supported by positive results from three major studies involving approximately 1,400 patients with the disease.
Data showed that up to 56% of Tremfya-treated CD patients achieved clinical remission after 12 weeks, compared to 15% to 22% of those receiving placebo. Additionally, endoscopic response was observed in 41% of patients in the Tremfya cohort versus 11% to 21% receiving placebo.
The regulator’s decision in UC was based on clinical trial results showing that 23% of patients treated with Tremfya reached clinical remission after 12 weeks of induction treatment, compared to 8% of those receiving placebo.
After 44 weeks, 50% of patients receiving continued maintenance treatment with Tremfya achieved clinical remission, compared to 19% of those in the placebo arm.
J&J also recently presented long-term results for Tremfya in UC, with 72% of patients in clinical remission at week 92 and 99% of these patients remaining corticosteroid free for eight or more weeks. Endoscopic remission was achieved by 43% of patients at week 92 and, among those achieving endoscopic improvement at week 44, 84% maintained endoscopic improvement to week 92.
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 [Tremfya] to treat CD and UC.
“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.”