October 21, 2019

The US FDA has approved a new indication for Stelara® (ustekinumab), manufactured by Janssen Pharmaceutical. The product is now indicated to treat adult patients who have moderately to severely active ulcerative colitis (UC).

Approximately 910,000 adults in the United States have UC, a chronic inflammatory bowel disease that causes ulcers and inflammation in the colon and rectum. Symptoms include abdominal pain, fatigue, weight loss, fever, bloody stool, urgent bowel movements, and diarrhea. The disease is progressive, with symptoms generally developing and worsening over time. Ulcerative colitis can cause disability and lead to life-threatening complications. Treatments include medication and surgical intervention.

In clinical studies, 19% of patients achieved clinical remission within eight weeks of receiving an initial dose of Stelara via intravenous (IV) infusion, while 58% of patients experienced a clinical response eight weeks following administration. Almost half (45%) of patients were in remission after one year of treatment with Stelara, and 43% of patients were in clinical remission without the use of corticosteroids.

Recommended dosing under the new indication requires one initial dose administered via IV infusion, with the dose ranging from 260mg to 520mg and based on the patient’s body weight. Eight weeks following the initial dose, patients should be switched to a maintenance dose of 90mg administered via subcutaneous (SC) injection once every eight weeks. Patients can self-administer the SC injection once properly trained by a healthcare professional.

First approved in 2009, Stelara is also indicated to treat adult patients who have moderate to severe plaque psoriasis, active psoriatic arthritis, or moderately to severely active Crohn’s disease, as well as adolescent patients who are at least 12 years of age and have moderate to severe plaque psoriasis.

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