Centocor, Inc., a biopharmaceutical company, reported that Remicade has received a Fast Track Designation from the US Food and Drug Administration (FDA) for the treatment of active ulcerative colitis (UC), a chronic and debilitating disease of the colon, or large intestine, that affects nearly a half million people in the United States.
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 (six-month versus standard 10-month review). There are currently no FDA approved biologic therapies to treat moderately-to-severely active UC, which may cause patients to face a colectomy (surgical removal of the colon).
"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, M.D., 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 500,0000 Americans living with UC. We look forward to working closely with the FDA through the application review process."
The use of Remicade for the treatment of UC is being investigated through two multicenters, 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.
Centocor, Inc., is planning simultaneous submissions of Remicade applications for the treatment of active UC in the United States and Europe. Centocor, Inc., discovered Remicade and has exclusive marketing rights to the product in the United States. Schering-Plough Corporation has rights to market Remicade in all countries outside of the United States, except in Japan and parts of the Far East where Tanabe Seiyaku, Ltd., markets the product.
Remicade is the global market leader among anti-tumour necrosis factor alpha (TNF-a) therapies and the only agent approved for the treatment of both rheumatoid arthritis (RA) and Crohn's disease (CD) in North America, the European Union and Japan, and was the first biologic approved for ankylosing spondylitis in the European Union. In the EU, Remicade is indicated for the treatment of ankylosing spondylitis in patients who have severe axial symptoms, elevated serological markers of inflammatory activity and who have responded inadequately to conventional therapy.
In September, the European Commission gave approval for expanded labelling for Remicade, in combination with methotrexate, for the treatment of active and progressive psoriatic arthritis in patients who have responded inadequately to disease modifying anti-rheumatic drugs.
Remicade is unique among available anti-TNF biologic therapies. Unlike self-administered therapies that require patients to inject themselves frequently, Remicade is the only anti-TNF biologic administered directly by caregivers in the clinic or office setting. In RA and CD patients, Remicade is a two-hour infusion administered every eight weeks, following a standard induction regimen that requires treatment at weeks zero, two and six. As a result, Remicade patients may require as few as six treatments each year. The safety and efficacy of Remicade have been well established in clinical trials over the past 12 years and through commercial experience with more than a half million patients treated worldwide.