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FDA Approves Stelara for Treatment of Adult Crohn's Disease

SEPTEMBER 26, 2016
RDR Staff
Crohn’s disease has been very fortunate this week to see two different FDA approvals for treatment of the disease.
 
Along with approving Amjevita, a biosimilar to adalimumab, the FDA has also just given the green light to Janssen Biotech’s Stelara (ustekinumab) for the treatment of moderately to severely active Crohn’s disease in patients 18 years or older.
 
Stelara is designed for patients who have failed or were intolerant to treatment with immunomodulators or corticosteroids or who failed or were intolerant to treatment with one or more TNF blockers.
 
The FDA approval is based on clinical data of statistical significant treatment of the disease.

Clinical Studies

In the Phase 3 clinical studies of 1,300 patients who were either new to, experienced with, or failed biologic therapy (TNF blockers), 34% (UNITI-1 study) to 56% (UNITI-2 study) of patients experienced relief from their Crohn’s disease symptoms in 6 weeks after receiving the one-time intravenous infusion of Stelara.
 
Patients who continued Stelara, subcutaneous maintenance doses every 8 weeks were in remission at the end of 44 weeks (52 weeks from initiation of the induction dose).

About Stelara

Stelara is the only approved treatment for Crohn’s disease that starts with a weight-based, one-time intravenous (IV) infusion induction dose (260 mg [55 kg or less], 390 mg [more than 55 kg to 85 kg], or 520 mg [more than 85 kg]) to help reduce symptoms, followed by 90 mg subcutaneous maintenance injections every 8 weeks to help keep the symptoms under control.

About Crohn’s disease

Crohn's disease is an inflammatory bowel disease (IBD). It causes inflammation of the lining of your digestive tract, which can lead to abdominal pain, severe diarrhea, fatigue, weight loss and malnutrition. Inflammation caused by Crohn's disease can involve different areas of the digestive tract in different people.
 
Crohn's disease can be both painful and debilitating, and sometimes may lead to life-threatening complications.


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