Johnson & Johnson’s TREMFYA Receives FDA Approval for Ulcerative Colitis, Expanding Treatment Options

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).

Mechanism of Action:
TREMFYA is a fully-human, dual-acting monoclonal antibody that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23.

Clinical Efficacy:
The approval is based on data from the pivotal Phase 2b/3 QUASAR study, which showed highly statistically significant rates of endoscopic remission at one year. Specifically, 50% of patients receiving TREMFYA 200 mg subcutaneous (SC) maintenance every four weeks and 45% of patients receiving 100 mg SC maintenance every eight weeks achieved clinical remission.

Safety Profile:
The study reaffirmed the established safety profile of TREMFYA, with common adverse reactions including arthralgia and upper respiratory tract infection.

Market Impact:
This approval strengthens Johnson & Johnson’s leadership in inflammatory bowel disease and expands treatment options for patients with ulcerative colitis.

Previous Approvals:
TREMFYA is also approved for the treatment of moderate-to-severe plaque psoriasis and active psoriatic arthritis.

Prevalence of Ulcerative Colitis:
More than one million people in the U.S. are living with UC, making it one of the largest populations globally affected by this disease, and the prevalence continues to rise.