**Johnson & Johnson’s (J&J) Tremfya (guselkumab) has been approved by the US Food and Drug Administration (FDA) to treat adults with moderately to severely active Crohn’s disease (CD).**
CD is one of the two main forms of inflammatory bowel disease (IBD), which affects an estimated three million people in the US. Symptoms vary, but often include abdominal pain and tenderness, frequent diarrhoea, rectal bleeding, weight loss and fever.
Offering both subcutaneous and intravenous induction options for CD, Tremfya is designed to block IL-23, an important driver of immune-mediated diseases, while also binding to CD64, a receptor on cells that produce IL-23.
Chris Gasink, vice president, medical affairs, gastroenterology and autoantibody, J&J Innovative Medicine, outlined that Tremfya is “the first and only IL-23 inhibitor that offers a fully subcutaneous treatment option for moderately to severely active CD”, adding that the approval makes it “possible to achieve meaningful improvements in clinical and endoscopic outcomes with the flexibility of self-administration from the start”.
Tremfya is already approved in the US to treat ulcerative colitis, the other main type of IBD, as well as plaque psoriasis and psoriatic arthritis.
The FDA’s latest decision on the drug was based on evidence from multiple phase 3 trials evaluating more than 1,300 patients with moderately to severely active CD who failed or were intolerant to conventional therapy or biologics.
This included results from late-stage GRAVITI programme, in which Tremfya was superior to J&J’s Stelara (ustekinumab) across all pooled endoscopic endpoints.
Lead investigator of the phase 3 GRAVITI study Remo Panaccione, the University of Calgary, said: “Despite the progress in the management of CD, 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.”
The authorisation comes just two weeks after J&J’s Lazcluze (lazertinib) was [approved](https://pmlive.com/pharma_news/jjs-rybrevant-lazcluze-combination-granted-mhra-approval-for-lung-cancer/) by the Medicines and Healthcare products Regulatory Agency as part of a combination treatment for a subset of lung cancer patients.