Janssen submits Stelara for EU approval for Crohn’s
pharmafile | December 9, 2015 | News story | Sales and Marketing |  Crohn’s disease, EMA, European Medicines Agency, Janssen, Stelara, crohn's disease, ustekinumabÂ
Janssen today announced that it has submitted an application to the European Medicines Agency, seeking approval of Stelara in Crohn’s disease.
The application is supported by data from the Phase III UNITI clinical development program, which includes three studies (UNITI-1, UNITI-2 and IM-UNITI) evaluating the efficacy and safety of Stelara (ustekinumab) treatment in patients with moderately to severely active Crohn’s disease.
Data from the UNITI-2 study were recently presented at the American College of Gastroenterology and United European Gastroenterology Week annual meetings, and results from the UNITI-1 and IM-UNITI studies will be presented at future medical congresses.
Stelara is already approved in the UK for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis. The drug is a human monoclonal antibody that targets interleukin (IL)-12 and IL-23 cytokines believed to play an important role in immune-mediated diseases, including Crohn’s disease.
Crohn’s disease is a chronic inflammatory bowel disease that affects the lining of the digestive tract. It affects approximately 115,000 people in the UK and is associated with abnormalities of the immune system that could be triggered by a genetic predisposition or diet and other environmental factors. The cause of Crohn’s disease is not known and there is currently no cure.
A recent study suggests dramatic growth in the number of young people in England admitted to hospital with the disease. According to the Health and Social Care Information Centre, 4,937 16-29-year-olds were admitted for treatment in England in 2003/4. By 2013, the figure had nearly quadrupled to 19,405.
Dr Rozlyn Bekker, medical director at Janssen UK, comments: “At Janssen, we are committed to ensuring that people living with Crohn’s disease can access and benefit from a variety of treatment options. We are pleased to submit the application seeking approval of ustekinumab for the treatment of moderately to severely active Crohn’s disease in Europe. When the time comes, we look forward to working closely with NICE and others to ensure that this important treatment is made available to patients.”
Joel Levy
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