CHMP Positive for Tremfya in UC
Johnson & Johnson announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended expanding the Marketing Authorisation for Tremfya (guselkumab) to include the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment
The positive CHMP opinion for guselkumab is based on data from the Phase III QUASAR programme. In the QUASAR induction and maintenance studies, guselkumab achieved the primary endpoint of clinical remission in both studies and showed statistically significant and clinically meaningful improvements relative to placebo in symptoms. Seven of nine prespecified, multiplicity-controlled major secondary endpoints, including clinical, endoscopic, histologic, symptomatic, and patient-reported outcome measures, were met in the induction study and all nine were met in the maintenance study for both dose regimens. The safety results were consistent with the known safety profile of guselkumab in approved indications
Guselkumab is the first approved fully-human, dual-acting IL-23p19 subunit inhibitor that blocks IL-23 and binds to CD64, a receptor on cells that produce IL-23. IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases including ulcerative colitis and Crohn’s disease. Guselkumab is approved in the European Union (EU) for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy and for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug therapy.
The European Commission will review the CHMP recommendation to determine issuing an expanded Marketing Authorisation, and a decision is expected in due course.
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