Tremfya Approved for Crohn’s Disease

FDA has approved a Johnson & Johnson supplemental BLA for Tremfya (guselkumab) and its use in treating adults with moderately to severely active Crohn’s disease, a chronic gastrointestinal tract disorder. Tremfya is described by the company as the only approved dual-acting monoclonal antibody that blocks interleukin (IL)-23 while also binding to CD64, a receptor on cells that produce IL-23.

Approval is based on data from Phase 3 trials evaluating more than 1,300 patients demonstrating that Tremfya was superior to the company’s Stelara (Ustekinumab) in “all pooled endoscopic endpoints, the only IL-23 inhibitor to achieve this in a double-blinded registrational program,” the company says.

This is the fourth indication for Tremfya; it is also approved for moderate-to-severe plaque psoriasis, active psoriatic arthritis, and moderately to severely active ulcerative colitis.