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FDA APPROVES NEW TREATMENT FOR CROHN'S DISEASE

FDA has approved Entocort EC® (budesonide) capsules for the treatment of mild to moderate active Crohn's Disease involving certain sections of the small and large intestines.

Crohn's Disease is a chronic inflammatory bowel disease that causes patients to develop diarrhea, at times profuse, abdominal pain or cramping, fever, fatigue, anorexia and weight loss. The causes of Crohn's Disease are unknown.

Entocort EC® is an orally administered steroid that is released in the intestine, where it works locally and topically to decrease inflammation.

Patients taking Entocort EC® experience fewer of the typical side effects associated with other steroids used to treat Crohn's Disease, such as prednisone or prednisolone tablets, because most of Entocort EC® is not absorbed into the body.

Prior to approval, Entocort EC® was studied in 651 patients with active Crohn's disease. Patients treated with Entocort EC® experienced significant improvement in their symptoms.

In the patients studied, the most common adverse events associated with Entocort EC® were headache, respiratory infection, and nausea. In addition, fewer patients receiving Entocort EC® experienced facial swelling and acne than those receiving prednisolone.

AstraZeneca LP of Wilmington, Del. is the sponsor of the approved New Drug Application (NDA) for Entocort EC®.

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