Janssen-Cilag seeks expanded EMA approval for TREMFYA
2024-05-02
临床3期临床结果上市批准
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来源: Pharmaceutical Technology
The approval of TREMFYA is sought for treating adults with active ulcerative colitis and Crohn’s disease. Credit: Jo Panuwat D / Shutterstock.com.
Johnson & Johnson company Janssen-Cilag International has filed applications with the European Medicines Agency (EMA) seeking to expand the marketing authorisation application for TREMFYA (guselkumab) to treat adults with active ulcerative colitis and Crohn’s disease.
The applications are based on positive results from the randomised, double-blind, placebo-controlled, multicentre Phase III QUASAR and GALAXI clinical trial programmes in ulcerative colitis and Crohn’s disease respectively.
The two trials assessed the safety and efficacy of guselkumab in adult patients with moderately to severely active ulcerative colitis or with Crohn’s who showed an inadequate response to or intolerance of standard treatment.
Guselkumab met the primary endpoint and offered improvements over placebo in symptoms and disease activity measures.
Its safety profile was in line with the previous findings of the therapy in approved indications.
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Data from the Phase III GALAXI 2 and 3 studies showed that guselkumab met the co-primary endpoints at week 12.
Treatment with guselkumab also offered statistically significant and clinically meaningful improvements versus placebo in corticosteroid-free clinical remission and endoscopic response at week 48.
Janssen-Cilag Immunology Therapeutic area lead senior director Ludovic de Beaucoudrey stated: “Inflammatory bowel disease, which includes ulcerative colitis and Crohn’s disease, affects as many as four million people in Europe annually.
“We look forward to working closely with the EMA during the review of these applications and are deeply committed to rapidly innovating for those patients who live with immune-mediated diseases like ulcerative colitis and Crohn’s disease where considerable needs remain.”
Guselkumab has been approved in the EU to treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy and also to treat psoriatic arthritis in adult patients who have had an insufficient response or who have been intolerant of a previous disease-modifying antirheumatic drug therapy.
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