Johnson & Johnson (J&J) has announced that its dual-acting IL-23 inhibitor Tremfya (guselkumab) has been approved by the European Commission (EC) to treat adults with ulcerative colitis (UC).
Patients eligible for the drug will have moderately to severely active cases of the disease and have had an inadequate response, lost response, or been intolerant to either conventional therapy or a biologic treatment.
Over 2.5 million people in Europe are living with UC, one of the two main forms of inflammatory bowel disease (IBD). Patients can experience a range of unpredictable symptoms, including loose and more frequent bowel movements, bloody stools, abdominal pain and loss of appetite.
Tremfya is designed to block IL-23, an important driver of the pathogenesis of inflammatory diseases, and is already approved in the EU to treat plaque psoriasis and psoriatic arthritis.
For the treatment of UC, the drug is given as a 200mg induction dose intravenously at weeks zero, four and eight, followed by a recommended subcutaneous (SC) maintenance dose of 100mg at week 16 and then every eight weeks, or 200mg at week 12 and every four weeks thereafter for patients who do not show adequate therapeutic benefit to induction treatment.
The EC’s latest decision follows a recent recommendation from the European Medicines Agency’s human medicines committee and was supported by results from the QUASAR programme, comprising a phase 2b induction dose-ranging study, and phase 3 induction and maintenance studies.
In the maintenance trial, 45% of patients receiving a 100mg SC maintenance dose of Tremfya every eight weeks and 50% of those being treated with a 200mg SC dose of the drug every four weeks achieved the primary endpoint of clinical remission at week 44, compared to 19% of placebo-treated patients.
Mark Graham, senior director, therapeutic area lead, immunology, J&J Innovative Medicine EMEA, said: “There is significant need for new UC therapies that offer meaningful improvements in symptoms and the promise of remission – both overall clinical remission and visible healing of the colon through endoscopic normalisation.”
“We look forward to seeing [Tremfya] continue to raise the bar of efficacy and become the new standard of care in the treatment of UC,” he added.
The EC is also reviewing a recommendation from the Committee for Medicinal Products for Human Use for Tremfya in Crohn’s disease, the other main form of IBD.