TREMFYA (guselkumab) Gets Positive CHMP Opinion for Crohn’s Disease

Recommendation based on the findings from the Phase 3 studies (GALAXI programme and GRAVITI) in Crohn’s disease 

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 Crohn’s disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment. This application included both subcutaneous (SC) and intravenous (IV) options for induction treatment. This follows a positive CHMP opinion for guselkumab for the treatment of patients with moderately to severely active ulcerative colitis earlier this year^.

The positive CHMP opinion for guselkumab for Crohn’s disease was based on a review of data from the Phase 3 GALAXI and GRAVITI programmes. In the GALAXI programme, at Week 12 guselkumab achieved the co-primary endpoints of clinical remission^a and endoscopic response, and the major secondary endpoints of PRO-2 remission^c and fatigue response, demonstrating statistically significant and clinically meaningful improvements in symptoms relative to placebo. These studies also showed a significantly greater proportion of patients were in corticosteroid-free clinical remission at Week 48 and endoscopic response at Week 48 in the guselkumab treated group compared to placebo.

Significantly, from the pooled GALAXI 2 and 3 study results, guselkumab also demonstrated greater efficacy compared to ustekinumab in endoscopic response and endoscopic remission at Week 48.

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In the Phase 3 GRAVITI study, a SC induction dose regimen was evaluated as an alternative to the IV induction dose regimen that was evaluated in the GALAXI 2 and 3 studies. In the GRAVITI study, both co-primary endpoints of clinical remission and endoscopic response at Week 12 relative to placebo were achieved. In addition, all secondary endpoints (PRO-2 remission and clinical response) at Week 12, and clinical remission at Week 24 demonstrated significant results compared with placebo.³

Safety results from both GALAXI studies and the GRAVITI study were consistent with the known safety profile of guselkumab in approved indications.

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“The results from the Phase 3 studies demonstrate guselkumab has the potential to become the only IL-23 inhibitor to offer both SC and IV induction options for Crohn’s disease”, said Mark Graham, Senior Director, Therapeutic Area Lead, Immunology, J&J Innovative Medicine EMEA. “Today’s positive opinion by the CHMP marks an important step forward in offering a potentially new and differentiated treatment option for people living with this chronic and debilitating condition, which affects around two million people in Europe.⁶ We look forward to the European Commission’s decision for both ulcerative colitis and Crohn’s disease and the opportunity to bring guselkumab to patients living with inflammatory bowel disease.”

Guselkumab is the first approved in-vitro fully-human, dual-acting IL-23p19 subunit inhibitor that blocks IL-23 and binds to CD64, a receptor on cells that produce IL-23.^5,7,8,9 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.^5,10 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.⁵

The European Commission will review the CHMP recommendation to determine issuing an expanded Marketing Authorisation, and a decision for use in Crohn’s disease is expected in due course.

ABOUT THE GRAVITI Phase 3 study (EudraCT 2020-006165-11)

GRAVITI is a treat-through, double-blind, placebo-controlled, parallel group, multicenter study to evaluate the efficacy and safety of guselkumab subcutaneous induction therapy in 350 participants with moderately to severely active Crohn’s disease with inadequate response or failure to tolerate previous conventional therapy (corticosteroids or immunomodulators) or biologic therapy (infliximab, adalimumab, certolizumab pegol, vedolizumab).² The study has a treat-through design in which participants remained on the treatment to which they were initially randomised and includes a long-term extension that will assess clinical, endoscopic, and safety outcomes with guselkumab through a total of five years.³

ABOUT CROHN’S DISEASE

Crohn’s disease is one of the two main forms of inflammatory bowel disease, which affects an estimated nearly two million people across Europe. Crohn’s disease is a chronic inflammatory condition of the gastrointestinal tract with no known cause, but the disease is associated with abnormalities of the immune system that could be triggered by a genetic predisposition, diet, or other environmental factors. Symptoms of Crohn’s disease can vary, but often include abdominal pain and tenderness, frequent diarrhoea, rectal bleeding, weight loss, and fever. There is currently no cure for Crohn’s disease.

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Source – GlobalNewswire