Johnson & Johnson (J&J) has received the US Food and Drug Administration (FDA) approval for Tremfya (guselkumab) to treat adults with active Crohn’s disease.
Tremfya is a dual-acting monoclonal antibody that blocks IL-23 and binds to CD64, a receptor on cells producing IL-23, linked to immune-mediated diseases like Crohn’s disease.
The drug offers both subcutaneous and intravenous induction options for managing the chronic inflammatory condition of the gastrointestinal tract.
Tremfya 400mg is recommended as a subcutaneous induction dosage at weeks 0, 4, and 8, with a maintenance dosage of 100mg every eight weeks or 200mg every four weeks.
An intravenous induction option of 200mg at weeks 0, 4, and 8 is also available.
Johnson & Johnson Innovative Medicine medical affairs, gastroenterology and autoantibody vice president Chris Gasink said: “TREMFYA is the first and only IL-23 inhibitor that offers a fully subcutaneous treatment option for moderately to severely active Crohn’s disease.
“With the approval of TREMFYA, it is now possible to achieve meaningful improvements in clinical and endoscopic outcomes with the flexibility of self-administration from the start.
“TREMFYA provides people living with Crohn’s disease and their healthcare providers a new treatment option that is supported by data from multiple Phase 3 studies, including pooled analyses showing statistical superiority versus STELARA across four endoscopic or combined clinical and endoscopic endpoints.”
The FDA approval builds on Tremfya’s existing FDA approval for treating active ulcerative colitis, another form of inflammatory bowel disease.
It is supported by data from multiple Phase 3 trials involving more than 1,300 patients with Crohn’s disease who did not respond to conventional therapies or biologics.
The GRAVITI study evaluated Tremfya’s subcutaneous induction and maintenance therapy against a placebo, while the GALAXI programme showed Tremfya’s superiority over Stelara.
It is the fourth indication for Tremfya in the US, following approvals for moderate-to-severe plaque psoriasis, active psoriatic arthritis, and moderately to severely active ulcerative colitis.
Phase 3 GRAVITI study lead investigator Remo Panaccione said: “Despite the progress in the management of Crohn’s disease, many patients experience debilitating symptoms and are in need of new treatment options.
“The approval of TREMFYA offers an IL-23 inhibitor that has shown robust rates of endoscopic remission with both subcutaneous and intravenous induction regimens.
“Importantly, the fully subcutaneous regimen offers choice and flexibility for patients and providers that have not been available before.”
