The Drug Stelara Gains Approval for Moderate to Severe Ulcerative Colitis in the EU

According to a story from BioSpace, Janssen Pharmaceutical Companies recently announced that the European Commission (EC) has expanded the approved indication of the company’s drug ustekinumab (marketed as Stelara). This approval will allow for the use of Stelara in adult patients with moderate to severe ulcerative colitis, a rare form of inflammatory bowel disease. The drug will be used in patients whose either fail to respond to other treatments or are otherwise unable to use them. This disease is estimated to affect more than two million people in Europe.

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.

About Stelara (ustekinumab)

Stelara is a drug that targets the IL-12/IL-23 molecular pathway. The approval comes following impressive results from a phase 3 clinical trial which tested the drug in patients with ulcerative colitis. Stelara is currently under consideration for approval by the US Food and Drug Administration (FDA) for the same disease.

The drug is also approved for plaque psoriasis in adult patients who are unresponsive to other therapies as well as in patients who are 12 or older. Stelara can also be used either on its own or in combination with methotrexate to treat adults with psoriatic arthritis. The therapy is also approved for Crohn’s disease, an illness that is closely related to ulcerative colitis.

Ulcerative colitis patients in this region who can’t use other treatments will now have a backup treatment that can help them find symptom relief.


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