AZN
Wednesday October 3, 1:52 pm Eastern Time
Press Release
SOURCE: AstraZeneca
AstraZeneca Receives FDA Approval for ENTOCORT(TM) EC (budesonide) Capsules For Crohn's Disease
ENTOCORT EC Offers Patients With Mild to Moderate Disease An Effective and Well-Tolerated New Treatment
WILMINGTON, Del., Oct. 3 /PRNewswire/ -- AstraZeneca announced today that it received U.S. Food and Drug Administration (FDA) approval to market ENTOCORT(TM) 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. ``In addition, with the FDA's approval of new drugs, such as ENTOCORT EC, patients have more treatment options.'
ENTOCORT EC allows patients the convenience of once daily dosing -- 9 mg (3x3 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.
The wholesaler acquisition cost (WAC) for ENTOCORT EC is $1.81/capsule for a 3 mg capsule. The WAC is the catalog list price at which AstraZeneca sells ENTOCORT EC capsules to wholesalers. The actual acquisition cost for individual pharmacies and patients may vary. The recommended adult dosage for ENTOCORT EC is 9mg (three 3 mg capsules) taken once daily in the morning for up to eight weeks.
``It is with great pride that AstraZeneca offers ENTOCORT EC to the medical community,' said Douglas Levine, M.D., Chief Medical Officer, Gastrointestinal Therapeutic Area, AstraZeneca. ``As we broaden our gastrointestinal franchise, which includes PRILOSEC® (omeprazole) and NEXIUM® (esomeprazole magnesium), AstraZeneca continues its commitment to discover and develop high- quality medicines in this important therapeutic area.'
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.
AstraZeneca (NYSE: AZN - news) is a major international healthcare business engaged in the research, development, manufacture and marketing of ethical (prescription) pharmaceuticals and the supply of healthcare services. It is one of the top five pharmaceutical companies in the world with healthcare sales of $15.8 billion and leading positions in sales of gastrointestinal, oncology, anesthesia (including pain management), cardiovascular, central nervous system (CNS) and respiratory products. In the United States, AstraZeneca is an $8 billion healthcare business with more than 10,000 employees.
For more information, please visit www.astrazeneca-us.com. For more information or a copy of the full prescribing information for ENTOCORT EC, NEXIUM or PRILOSEC contact Jim Coyne at 1-800-942-0424, ext. 1656, or via e-mail at jim.coyne@astrazeneca.com. Register at www.entocortec.com to receive notification about the availability of disease and product information at this web site.
For more information about Crohn's disease, please call CCFA at 800-343-3637, or visit www.ccfa.org.
Fred |
