FDA Approves REMICADE (R) (Infliximab) Fast Track Designation for ulcerative colitis
Centocor, Inc., announced today that REMICADE (reg) has received fast track designation from the Food and Drug Administration (FDA) for treatment of ulcerative colitis (UC), a chronic and debilitating disease of the colon or large intestine, which affects nearly half a million people in the United States. The DFA fast track rules, based on the Law of Modernization of the FDA in 1997, are designed to assist in the development of products that may treat serious or life-threatening and to respond to an unmet medical need.received FDA priority review (six months vs. 10 months for standard review). There are currently no FDA approved biologic therapies for the treatment of moderate to severe active UC, which may cause can provide patients colectomy (surgical removal of the
colon). Currently, there is a strong unmet need in the treatment of ulcerative colitis, particularly 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.is much needed treatment option for Americans living with UC 500.0000. We look forward to working closely with the FDA in the review process of applications. The use of REMICADE (reg) for the treatment of UC is studied through two multicenter, phase III, randomized, double-blind, placebo-controlled-controlled, parallel treatment in clinical trials to evaluate the safety and efficacy of treatments in patients with active UC.
in Chicago in May 2005. Centocor, Inc., is planning the
simultaneous presentation of Remicade (REG) applications for the treatment of active UC in the United States and Europe. Centocor, Inc., has discovered REMICADE (reg) and has exclusive rights to market the product in the United States. Schering-Plough Corporation has the right to market REMICADE (reg) in all countries outside the United States, except in Japan and parts of the Far East where Tanabe Seiyaku, Ltd. markets the Pages: [1] 2 3 4