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 Crohns 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...
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Remicade và Azilect 1) Remicade và Azilect 1) FDA cho phép dùng thuốc mới Remicade (infliximab) cho việc điềutrị bệnh viêm ruột Crohn’s disease. Remicade là một loại thuốc do điều chếkháng thể đơn dòng (monoclonal antibody). Thuốc giảm hiện tượng viêmbằng 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 Crohns disease, a chronic,inflammatory condition of the bowel that can be severely debilitating.Remicade is a genetically engineered monoclonal antibody, which reducesinflammation (swelling/redness) by blocking the action of tumor necrosisfactor-alpha (TNF-α), that was initially approved in 1998 to treat Crohnsdisease in adults. Dr. Steven Galson, director of the FDAs Center for Drug Evaluationand Research, noted that there have been no satisfactory treatments forchildren with Crohns disease who have moderate to severe disease activitydespite traditional or conventional therapies. Crohns disease can causediarrhea, cramping, abdominal pain, gastrointestinal bleeding, and in somecases creates abnormal connections (fistulas) leading from the intestine tothe skin. Remicade is not a cure, but it provides a much-needed option forreducing the symptoms and inducing and maintaining disease remission inchildren who have no other safe and effective therapy, he said. We believethat the potential benefits of this product outweigh the risks that are knownand have been carefully evaluated. The safety and effectiveness of Remicade in pediatric Crohns diseasewere assessed in a randomized study in 112 children who were 6 to 17 yearsold with moderately to severely active Crohns disease who had aninadequate response to conventional therapies. The proportion of these patients who achieved clinical responsecompared favorably with the proportion of adults in an earlier Remicadestudy in adult Crohns disease, and the pediatric trials results showed no newsafety concerns not already expressed in the products current label. In general, the safety profile for Remicade in the pediatric trial wassimilar to the data that was presented at an FDA Arthritis AdvisoryCommittee meeting in March 2003, and that dealt with the extent to whichanti-TNF therapies may increase the risk of serious infections andmalignancies, such as sepsis and pneumonia in certain patients. These risks, which are described in a study in the May 17 issue of theJournal of the American Medical Association, are included in the currentlabels for all approved TNF-alpha blocking agents, including Remicade. More recently, the FDA has received rare post-marketing reports of anaggressive and often fatal type of T-cell lymphoma (hepatosplenic T-celllymphoma) in adolescent and young adult patients with the Crohns disease.In most, but not all cases, these patients were treated with standardimmunosuppressive therapies (azathioprine or 6-mercaptopurine) incombination with Remicade. The FDA is working with the manufacturer toaddress this risk by updating the Warnings sections of the Remicade label. FDA continues to actively and carefully monitor the safety experiencewith Remicade and similar therapies in an effort to maximize their very realbenefits yet limit, to the degree possible, the potential for very serioustoxicities. 2) FDA cho phép dùng thuốc mới Azilect (rasaziline) trong việc điềutrị bệnh thần kinh Parkinson. Thuốc Azilect là loại kìm hãm monoamineoxidase type B không cho dopamine bị thoái hóa. Dopamine là một hóa chấtđưa những thông tin tơí các phần của não, cần thiết trong việc điều hành cửđộng và phối hợp của cơ thể. FDA Approves New Treatment for Parkinsons Disease The Food and Drug Administration today approved Azilect(rasagiline), a new molecular entity, for the treatment of Parkinsons disease.The drug is a monoamine oxidase type--B (MAO-B) inhibitor that blocks thebreakdown of dopamine, a chemical that sends information to the parts ofthe brain that control movement and coordination. This is a welcome development for the more than 50,000 Americanswho are each year diagnosed with Parkinsons disease, said Dr. StevenGalson, Director of the Center for Drug Evaluation and Research.Parkinsons is a relentless disease with limited treatment options, and eachnew therapy is an important addition to the physicians treatment options.Parkinsons disease is a chronic, progressive neurodegenerative conditioncaused by the destruction of the brain cells that produce dopamine. As thelevel of this chemical declines, messages from the brain telling the body howand when to move are delivered more slowly, leaving a person incapable ofinitiating and controlling movements in a normal way. Azilect was approved for use as an initial single drug therapy in earlyParkinsons disease, and as an addition to levodopa in more advancedpatients. Levodopa is a standard treatment for Parkinsons disease. Thesafety and effectiveness of Azilect was demonstrated in three 18- to 26-weekcontrolled clinical trials. One of the studies compared the effects of Azilect with the effects ofplacebo in 404 patients with early Parkinsons. Compared with patients onplacebo, the condition of patients on Azilect showed significantly lessworsening on a rating scale that measures the ability to perform mental andmotor tasks as well as daily living activities. The other two studies compared the effects of Azilect with placebowhen taken together with levodopa by over 1100 patients with moreadvanced Parkinsons. In these studies, patients using Azilect together withlevodopa had signi ...