FDA cho phép dùng thuốc mới Remicade (infliximab) cho việc điều trị bệnh viêm ruột Crohn’s disease. Remicade là một loại thuốc do điều chế kháng thể đơn dòng (monoclonal antibody). Thuốc giảm hiện tượng viêm bằng cách ngăn chặn yếu tố tumor necrosis factor-alpha (TNF-alpha). FDA Approves Remicade for Children with Crohn’s Disease The Food and Drug Administration today approved Remicade (infliximab) to treat children with active Crohn's disease, a chronic, inflammatory condition of the bowel that can be severely debilitating. Remicade is a genetically engineered monoclonal antibody, which reduces inflammation (swelling/redness) by blocking the action of tumor. | Remicade và Azilect 1 FDA cho phép dùng thuốc mới Remicade infliximab cho việc điều trị bệnh viêm ruột Crohn s disease. Remicade là một loại thuốc do điều chế kháng thể đơn dòng monoclonal antibody . Thuốc giảm hiện tượng viêm bằng cách ngăn chặn yếu tố tumor necrosis factor-alpha TNF-alpha . FDA Approves Remicade for Children with Crohn s Disease The Food and Drug Administration today approved Remicade infliximab to treat children with active Crohn s disease a chronic inflammatory condition of the bowel that can be severely debilitating. Remicade is a genetically engineered monoclonal antibody which reduces inflammation swelling redness by blocking the action of tumor necrosis factor-alpha TNF-a that was initially approved in 1998 to treat Crohn s disease in adults. Dr. Steven Galson director of the FDA s Center for Drug Evaluation and Research noted that there have been no satisfactory treatments for children with Crohn s disease who have moderate to severe disease activity despite traditional or conventional therapies. Crohn s disease can cause diarrhea cramping abdominal pain gastrointestinal bleeding and in some cases creates abnormal connections fistulas leading from the intestine to the skin. Remicade is not a cure but it provides a much-needed option for reducing the symptoms and inducing and maintaining disease remission in children who have no other safe and effective therapy he said. We believe that the potential benefits of this product outweigh the risks that are known and have been carefully evaluated. The safety and effectiveness of Remicade in pediatric Crohn s disease were assessed in a randomized study in 112 children who were 6 to 17 years old with moderately to severely active Crohn s disease who had an inadequate response to conventional therapies. The proportion of these patients who achieved clinical response compared favorably with the proportion of adults in an earlier Remicade study in adult Crohn s disease and the pediatric trial s .
