FDA approves Johnson & Johnson’s TREMFYA in Crohn’s disease

The company states: “Johnson & Johnson announced that the FDA has approved TREMFYA, or guselkumab, the first and only IL-23 inhibitor offering both subcutaneous and intravenous induction options, for the treatment of adults with moderately to severely active Crohn’s disease, CD, a chronic inflammatory condition of the gastrointestinal tract. This milestone builds upon the FDA approval of TREMFYA in moderately to severely active ulcerative colitis, one of two main forms of inflammatory bowel disease which impacts the lives of nearly three million Americans.3 TREMFYA(R) is the first and only approved fully-human, dual-acting monoclonal antibody that blocks IL-23 while also binding 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 CD. This approval is supported by results from multiple rigorous Phase 3 trials evaluating more than 1,300 patients with moderately to severely active CD who failed or were intolerant to conventional therapy or biologics. The GRAVITI study evaluated TREMFYA(R) SC induction and maintenance therapy versus placebo. Data from the GALAXI clinical program showed TREMFYA(R) was superior to STELARA(R) in all pooled endoscopic endpoints, the only IL-23 inhibitor to achieve this in a double-blinded registrational program. The comprehensive results from these Phase 3 studies demonstrated the robust efficacy of SC or IV TREMFYA(R) in achieving clinical and endoscopic endpoints.”