To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Approves Entocort EC (Budesonide) For Crohn's Disease URL: http://www.pslgroup.com/dg/207CEA.htm Doctor's Guide October 3, 2001
WILMINGTON, DE -- October 3, 2001 -- AstraZeneca announced today that it received U.S. Food and Drug Administration (FDA) approval to market Entocort™ EC (budesonide) capsules for the treatment of mild-to-moderate, active Crohn's disease involving the ileum and/or ascending colon. Entocort EC is a new, locally active glucocorticosteroid that can lead many patients to experience a significant reduction in symptoms of a disease that is often difficult to treat. The New Drug Application for Entocort EC was given priority review in January.
"The FDA approval of Entocort EC signals an important advance in the treatment of Crohn's disease -- a disease for which there is a significant need for new medicines," said William J. Sandborn, MD, Professor of Medicine, Mayo Medical School and Head of Inflammatory Bowel Disease Research, Mayo Clinic. "Not only is Entocort EC a highly effective treatment for mild to moderate flare-ups involving the ileum and ascending colon, but it also has a good tolerability profile, making this treatment option attractive for both physicians and patients alike."
In five clinical trials of approximately 1,000 patients with mild to moderate, active Crohn's disease involving the ileum and/or ascending colon, Entocort EC was shown to be effective and well-tolerated. In these studies, 48 to 69 percent of patients treated with Entocort EC 9 mg once daily experienced clinical improvement after eight weeks. Clinical improvement was defined as achievement of a Crohn's Disease Activity Index (CDAI) score of less than or equal to 150.(1) At baseline, the median CDAI score ranged from 272 to 290.
The most common adverse events reported were headache, respiratory infection, nausea, and symptoms of hypercorticism. The frequency of glucocorticosteroid-associated adverse events was substantially reduced with Entocort EC compared with prednisolone (a systemic glucocorticosteroid used to treat Crohn's disease) at therapeutically equivalent doses.
Crohn's disease is a chronic inflammatory bowel disease of unknown origin. Flare-ups of the disease can range from mild to severe and involve symptoms such as diarrhea, crampy abdominal pain, fever and sometimes bleeding from the rectum. The condition can be difficult to manage, clinically. Treatment for the disease tends to consume a substantial amount of healthcare resources in terms of physician time, procedures and medications.
"Although Crohn's can be a debilitating and difficult disease to live with, patients should be encouraged by the recent advances in the research around this complex disease area," said Lisa H. Richardson, Chairperson of the Board, Crohn's & Colitis Foundation of America.
Entocort EC allows patients the convenience of once daily dosing -- 9 mg (three, 3 mg capsules) per day. The safety and efficacy of Entocort EC in the treatment of active Crohn's disease has not been established beyond eight weeks. The active ingredient in Entocort EC is released in the intestines, the primary target site for Crohn's disease, and is then quickly and extensively metabolized, preventing the majority of the drug from entering the systemic circulation.
Entocort EC is contraindicated in patients with known hypersensitivity to budesonide. Glucocorticosteroids can reduce the response of the hypothalamus-pituitary-adrenal (HPA) axis to stress. In patients treated with Entocort EC, supplementation with a systemic glucocorticosteroid is recommended before surgery or other stress situations. Adrenocortical function monitoring may be required in patients being transferred to Entocort EC from a systemic glucocorticosteroid. Patients taking corticosteroids should avoid exposure to infections such as chicken pox or measles.
References:
(1) The CDAI is a validated index based on subjective aspects rated by the patient (frequency of liquid or very soft stools, abdominal pain rating, and general well-being) and objective observations (number of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal mass, body weight, and hematocrit).
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