Active ulcerative colitis is a chronic and debilitating disease of the colon, or large intestine, that affects nearly a half million people in the United States.
Remicade is the global market leader among anti-tumor necrosis factor alpha (TNF-a) therapies.
It is the only agent approved for the treatment of both rheumatoid arthritis (RA) and Crohn's disease (CD) in North America, the European Union (EU) and Japan.
The FDA's Fast Track regulations, based upon the FDA Modernization Act of 1997, are designed to assist in the development of products that may treat serious or life-threatening diseases and address an unmet medical need.
Development programs receiving Fast Track Designations typically receive FDA Priority Review (6-month vs. standard 10-month review).
There are currently no FDA approved biologic therapies to treat moderately-to-severely active ulcerative colitis, which may cause patients to face a colectomy.
| Remicade for UC is being investigated through 2 multicenter, Phase III randomized, double-blind, placebo-controlled, parallel-treatment clinical trials|
"There is currently a significant unmet need in the treatment of UC, especially when you consider that surgery is often the only option when conventional therapies fail," said Jerome A. Boscia, MD, Senior Vice President, Clinical Research and Development, Centocor, Inc.
"Once data are submitted to the FDA, a Fast Track Designation could be an important step in providing a much-needed treatment option for the 500,000 Americans living with UC.
The use of Remicade for the treatment of UC is being investigated through 2 multicenter, Phase III randomized, double-blind, placebo-controlled, parallel-treatment clinical trials to evaluate the treatment's safety and efficacy in people with active UC.
Top-line data from these trials are expected to be presented during the Digestive Disease Week meeting in Chicago in May 2005.