Janssen-Cilag requests broader EMA approval for TREMFYA

Janssen-Cilag International, a subsidiary of Johnson & Johnson, has recently submitted applications to the European Medicines Agency (EMA) to expand the use of its drug TREMFYA (guselkumab) for treating adults with active ulcerative colitis and Crohn’s disease. This request is driven by positive outcomes from the Phase III QUASAR and GALAXI clinical trials, which investigated the drug's safety and efficacy in patients who had a poor response to or could not tolerate standard treatments.

In these trials, adult patients with moderate to severe ulcerative colitis or Crohn’s disease were administered guselkumab. The results demonstrated that the drug met the primary endpoint, showing significant improvements in symptoms and disease activity compared to a placebo. Additionally, the safety profile of guselkumab was consistent with earlier findings from its approved uses.

Further supporting the application, data from the Phase III GALAXI 2 and 3 studies highlighted that guselkumab achieved the co-primary endpoints by week 12. Beyond that, by week 48, patients treated with guselkumab experienced statistically significant and clinically meaningful improvements in corticosteroid-free clinical remission and endoscopic response compared to those who received a placebo.

Ludovic de Beaucoudrey, the senior director of the Immunology Therapeutic area at Janssen-Cilag, emphasized the significant impact of inflammatory bowel disease on millions of people in Europe each year. He expressed optimism about collaborating with the EMA during the review process and reaffirmed the company’s commitment to innovating treatments for patients with immune-mediated diseases such as ulcerative colitis and Crohn’s disease, where there are still substantial unmet needs.

TREMFYA is already approved in the European Union for treating adults with moderate to severe plaque psoriasis who are suitable candidates for systemic therapy. It is also authorized for use in adults with psoriatic arthritis who have not sufficiently responded to or have been intolerant of previous disease-modifying antirheumatic drug therapies.

With the new applications, Janssen-Cilag aims to address the treatment gaps for patients suffering from ulcerative colitis and Crohn’s disease, two debilitating conditions that significantly affect the quality of life for millions of individuals. The company’s proactive approach in seeking expanded indications for TREMFYA underscores its dedication to providing effective therapeutic solutions for chronic, immune-mediated diseases.