According to an article on Pharma Biz, Johnson & Johnson recently submitted a supplemental Biologics License Application to the US Food and Drug Administration (FDA). This application was for the approval of guselkumab (marketed as Tremfya) as a treatment for active Crohn’s disease that is considered moderate to severe in adult patients. Earlier in the year, the company submitted an application for the drug as a treatment for ulcerative colitis, another form of inflammatory bowel disease that is closely related to Crohn’s.
The submission follows data from two phase 3 trials. In the first, called GALAXI, guselkumab was compared alongside ustekinumab in the treatment of Crohn’s disease. Guselkumab was successful in meeting the primary endpoints and demonstrated its superiority versus utsekinumab. The second was called GRAVITI in which the drug was used as an induction therapy for Crohn’s. The treatment performed strongly in this study as well.
From these results, guselkumab demonstrated the potential to bring a new treatment option for patients that are failing to see impactful results from other available approaches. The drug is an inhibitor of IL-23, a cytokine that has been identified as a catalyst of inflammatory, immune-mediated illnesses.
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.
