FDA Approves Tremyfa to Treat Active Crohn’s Disease

The FDA has approved Johnson & Johnson’s supplemental application for Tremfya (guselkumab) to treat adults with moderately to severely active Crohn’s disease (CD), a chronic inflammatory condition of the gastrointestinal tract. Tremfya is available as both a subcutaneous (SC) and intravenous (IV) induction option.

About 1 million people in the United States have Crohn’s disease. It often develops gradually with symptoms such as diarrhea, abdominal pain and weight loss, called flares, that may get worse over time, according to the National Institute of Diabetes and Digestive and Kidney Diseases. The goal of treatment is to have symptoms to go into remission long-term.

“Despite the progress in the management of Crohn’s disease, many patients experience debilitating symptoms and are in need of new treatment options,” said Remo Panaccione, professor of Medicine and the director of the Inflammatory Bowel Disease Unit at the University of Calgary.

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. IL-23 is a cytokine that is a driver of immune-mediated diseases. It was approved by the FDA in September 2024 to treat adults with moderately to severely active ulcerative colitis (UC). Tremfya is also approved to treat patients with plaque psoriasis (2017) and active psoriatic arthritis (2020).

The list price of Tremfya is $13,872.80 per dose as of September 2024

J&J offers a $0 copay program for eligible commercially insured patients. In the terms for the copay assistance, J&J says that patients whose insurance companies apply the accumulator or maximizer program are not eligible for the copay assistance.

The approval in Crohn’s disease was supported by phase 3 trials evaluating more than 1,300 patients with moderately to severely active disease who failed or were intolerant to conventional therapy (i.e., corticosteroids or immunomodulators) or biologics.

The GRAVITI study evaluated Tremfya SC induction and maintenance therapy versus placebo. Data from the GALAXI clinical program showed Tremfya was superior to Stelara (ustekinumab) in all pooled endoscopic endpoints.

In December 2024, J&J submitted two supplemental biologics license applications (sBLAs) to the FDA for Tremfya to be used in children aged 6 and older with moderate-to-severe plaque psoriasis (PsO) and children aged 5 and older with active juvenile psoriatic arthritis (jPsA).

The sBLA submission for plaque psoriasis in children is based on the combined data of the ongoing phase 3 PROTOSTAR study examining the effects of Tremfya on pediatric patients and previous data from phase 3 VOYAGE 1 and 2 studies of adults with moderate-to-severe plaque psoriasis, in which 73.3% and 70.0% of patients saw improvement of psoriasis symptoms.

The sBLA submission for the juvenile psoriatic arthritis indication is based on the ongoing adult studies DISCOVER 1 and 2 and Tremfya safety data from the PROTOSTAR study, in which only 3% of the 731 total patients had serious adverse effects.