FDA Approves TREMFYA (Guselkumab) for Moderately to Severely Active Ulcerative Colitis

FDA Approval:
The U.S. Food and Drug Administration (FDA) has approved TREMFYA (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC).

First and Only Dual-Acting IL-23 Inhibitor:
TREMFYA is the first and only fully-human, dual-acting monoclonal antibody that targets both interleukin-23 (IL-23) and CD64, a receptor on cells that produce IL-23.

Clinical Efficacy:
The approval is based on the Phase IIb/III QUASAR study, which showed that TREMFYA demonstrated significant clinical and endoscopic improvements in UC patients, including high rates of endoscopic remission at one year.

Dosing and Administration:
TREMFYA is administered as a 200 mg induction dose intravenously at weeks zero, four, and eight, followed by a maintenance dosage of 100 mg administered by subcutaneous injection at week 16 and every 8 weeks thereafter, or 200 mg administered by subcutaneous injection at week 12 and every 4 weeks thereafter.

Safety Profile:
The QUASAR study reinforced the well-established safety profile of TREMFYA, including in the treatment of patients with UC.

Market Impact:
This approval strengthens Johnson & Johnson’s leadership in inflammatory bowel disease and positions TREMFYA as a successor to Stelara, which faces growing competition from biosimilars.