FDA Approves Budesonide for the Maintenance of Remission in Crohn's disease
May 11, 2005 - 9:58:00 AM
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"Physicians can now provide their patients with an effective long-term therapy option, in addition to an acute treatment related to mild to moderate active Crohn's disease. Our commitment is to continue to aid physicians in improving the lives of their patients through providing meaningful products and the FDA's additional approval is a significant component in keeping with that commitment."
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By Prometheus Laboratories Inc.,
[RxPG] Prometheus Laboratories Inc., a specialty pharmaceutical company, announced today that the U.S. Food & Drug
Administration (FDA) has approved the supplemental New Drug Application (sNDA)for the additional use of Entocort(R) EC (budesonide) Capsules for the maintenance of clinical remission of mild to moderate Crohn's disease involving the ileum and/or the ascending colon for up to three months.
Entocort EC is the only pharmacological product indicated for the treatment of mild to moderate Crohn's disease involving the ileum and/or the ascending colon, which affects nearly 70% of Crohn's patients.
"We are excited to have this additional indication for Entocort EC," said Joseph M. Limber, President and Chief Executive Officer of Prometheus. "Physicians can now provide their patients with an effective long-term therapy
option, in addition to an acute treatment related to mild to moderate active Crohn's disease. Our commitment is to continue to aid physicians in improving the lives of their patients through providing meaningful products and the FDA's additional approval is a significant component in keeping with that commitment."
The additional approval is based on the results of four double-blind, placebo-controlled, 12-month trials in which 380 patients were randomized and treated once daily with either 3 mg or 6 mg Entocort EC, or placebo. The median time to relapse in the pooled population of the 4 studies was 154 days for patients taking placebo, and 268 days for patients taking Entocort EC, at 6 mg/day.
Entocort EC at 6 mg/day significantly reduced the percentage of patients with loss of symptom control (28%) versus placebo (45%) in the pooled population for the 4 studies at three months.
Entocort EC is a topical glucocorticosteriod, working primarily in the intestines. Its specifically designed oral formulation allows local release in the ilium and the ascending colon. The adverse event profile in long-term
treatment was similar to that of short-term treatment with Entocort EC. The most common side effects of Entocort EC observed in clinical trials were headache, respiratory infection, nausea and symptoms of hypercorticism.
About Crohn's Disease
Crohn's disease is a chronic inflammatory bowel disease of unknown origin.An estimated 500,000 Americans have the disorder. Flare-ups of the disease can range from mild to severe and involve symptoms such as diarrhea, abdominal
pain, fever and sometimes rectal bleeding. The condition can be difficult to manage clinically and consumes a substantial amount of healthcare resources in terms of physician time, procedures and medications.
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Additional information about the news article
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About Prometheus
Prometheus Laboratories Inc. is a specialty pharmaceutical company committed to developing new ways to help physicians individualize patient care. Prometheus focuses on the treatment, diagnosis and detection of gastrointestinal, autoimmune and inflammatory diseases and disorders. Prometheus' strategy includes the marketing and delivery of pharmaceutical products complemented by its proprietary, high-value diagnostic testing services. By integrating therapeutics and diagnostic services, Prometheus addresses the continuum of patient care, thereby providing physicians with a comprehensive solution to treat chronic diseases. Prometheus' corporate offices are located in San Diego, California. Additional information about Prometheus can be found at http://www.prometheuslabs.com.
This press release contains certain "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995. To the extent that any statements made in this news release contain information that is not historical, these statements are essentially forward-looking and are subject to risks and ncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors. Prometheus cautions that any forward-looking information is not a guarantee of future performance. The Company may not successfully maintain or grow the market for Entocort EC for a variety of reasons.
Entocort is a registered trademark of the AstraZeneca group of companies.
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