According to reporting from News-Medical.net, Janssen-Cilag International NV recently announced that it had applied for European Medicines Agency (EMA) approval of its drug guselkumab (marketed as TREMFYA) in an expansion of its label for the treatment of moderate to severe Crohn’s disease and ulcerative colitis in adults. A similar application was submitted to the US Food and Drug Administration in March of this year by Johnson & Johnson.
Trial Findings
The application follows data from phase 3 trials, including the QUASAR program for ulcerative colitis and the GALAXI program for Crohn’s disease. In QUASAR, the drug achieved all primary endpoints and demonstrated meaningful improvements from placebo in symptoms and other evaluations of disease activity. Meanwhile, guselkumab also met the co-primary endpoints in GALAXI, which included improvements in endoscopic response and clinical remission relative to placebo.
About Guselkumab in the EU
This drug is the first ever fully human monoclonal antibody that inhibits IL-23 through the blockage of the p19 subunit. The cytokine IL-23 is a driver of immune-mediated conditions like inflammatory bowel disease, of which ulcerative colitis and Crohn’s are the principal variants. It is secreted by dendritic cells and active macrophages. Guselkumab is currently approve in the EU for moderate to severe plaque psoriasis for adult patients that are eligible for systemic therapies, as well as for psoriatic arthritis who have inadequate response to anti-rheumatic therapies or are intolerant of them.
You can read more at News-Medical.net. Johnson & Johnson’s press release about European regulatory application is here.
About Crohn’s Disease
Crohn’s disease is a form of inflammatory bowel disease which can impact any area of the digestive tract. The cause of the illness is not well understood, but a combination of environmental, genetic, bacterial, and immune system factors could play a role; smoking tobacco appears to increase risk. The disease is often identified in the teen years or early adulthood. While abnormal immune system behavior is also present, it is not considered an autoimmune disease. Symptoms include weight loss, abdominal distension, bowel obstruction, diarrhea, fever, abdominal pain, fatigue, and inflammation spreading to other areas (eyes, joints, etc.). Patients are at an elevated risk of cancer impacting the digestive tract. Treatment includes changes to diet, stopping smoking, steroids, immunosuppressants, and certain surgical operations. Symptoms tend to relapse and remit, and some patients are able to live mostly normal lives. However, there is no cure for Crohn’s disease and treatment must continue for life. Patients have a slightly reduced life expectancy. To learn more about Crohn’s disease, click here.
About Ulcerative Colitis
Ulcerative colitis is a long term condition which is characterized by the appearance of ulcers and generalized inflammation of the rectum and colon. The exact cause of the condition remains a mystery, but there do appear to be some risk factors, such as family history, diet, and exposure to the medication isotrentinoin. Smoking appears to have a slightly protective effect. Symptoms can include anemia, bloody diarrhea, weight loss, fever, and abdominal pain. They tend to appear in a relapsing-remitting pattern. In severe disease there is a risk of serious complications, such as megacolon or inflammatory disease in other parts of the body. The risk of colon cancer is also elevated. Treatment may include dietary changes, medication to control inflammation, and, when complications appear, surgery. To learn more about ulcerative colitis, click here.
