FDA APPROVALS

FDA Approves Crohn’s Disease Med

September 26, 2016

The US Food and Drug Administration (FDA) has approved ustekinumab (Stelara) to treat adult patients with moderately to severely active Crohn’s disease, Janssen Biotech announced Monday.

The drug is indicated for those “who have failed or were intolerant to treatment with immunomodulators or corticosteroids but never failed treatment with a tumor necrosis factor (TNF) blocker, or who failed or were intolerant to treatment with one or more TNF blockers,” according to a company statement.

The prescription medication is the first biologic therapy for the treatment of the chronic inflammatory bowel disease that targets interleukin (IL)-12 and IL-23 cytokines. Further, ustekinumab begins with a one-time intravenous (IV) infusion induction dose. The weight-based IV dose, which is aimed at reducing symptoms, is followed by subcutaneous maintenance injections every 2 months to maintain symptom control.
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FDA approval was largely based on the results of three Phase III studies involving more than 1300 patients. The studies demonstrated clinical response and clinical remission in those who received ustekinumab.

There are a number of common side effects, which include upper respiratory infection, headache, tiredness, joint pain, nausea, itching, vomiting, vaginal yeast infections, urinary tract infections, and redness at the injection site. Further, the medication may reduce one’s ability to fight infections and may increase one’s risk of developing infections.

 

-Meredith Edwards White

 

References:

1. Janssen Biotech. FDA approves STELARA (ustekinumab) for treatment of adults with moderately to severely active Crohn's disease [press release]. September 26, 2016.

2. Janssen Biotech. Welcome to Stelara. www.stelarainfo.com. Accessed September 26, 2016.