Remicade và Azilect 1)

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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...

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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-α), 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 results showed no new safety concerns not already expressed in the product's current label.
In general, the safety profile for Remicade in the pediatric trial was similar to the data that was presented at an FDA Arthritis Advisory Committee meeting in March 2003, and that dealt with the extent to which anti-TNF therapies may increase the risk of serious infections and malignancies, such as sepsis and pneumonia in certain patients. These risks, which are described in a study in the May 17 issue of the Journal of the American Medical Association, are included in the current labels for all approved TNF-alpha blocking agents, including Remicade. More recently, the FDA has received rare post-marketing reports of an aggressive and often fatal type of T-cell lymphoma (hepatosplenic T-cell lymphoma) in adolescent and young adult patients with the Crohn's disease. In most, but not all cases, these patients were treated with standard immunosuppressive therapies (azathioprine or 6-mercaptopurine) in combination with Remicade. The FDA is working with the manufacturer to address this risk by updating the Warnings sections of the Remicade label. FDA continues to actively and carefully monitor the safety experience with Remicade and similar therapies in an effort to maximize their very real benefits yet limit, to the degree possible, the potential for very serious toxicities.
2) FDA cho phép dùng thuốc mới Azilect (rasaziline) trong việc điều trị bệnh thần kinh Parkinson. Thuốc Azilect là loại kìm hãm monoamine oxidase type B không cho dopamine bị thoái hóa. Dopamine là một hóa chất đưa những thông tin tơí các phần của não, cần thiết trong việc điều hành cử động và phối hợp của cơ thể. FDA Approves New Treatment for Parkinson's Disease The Food and Drug Administration today approved Azilect (rasagiline), a new molecular entity, for the treatment of Parkinson's disease. The drug is a monoamine oxidase type--B (MAO-B) inhibitor that blocks the breakdown of dopamine, a chemical that sends information to the parts of the brain that control movement and coordination. "This is a welcome development for the more than 50,000 Americans who are each year diagnosed with Parkinson's disease, " said Dr. Steven Galson, Director of the Center for Drug Evaluation and Research. "Parkinson's is a relentless disease with limited treatment options, and each new therapy is an important addition to the physicians' treatment options." Parkinson's disease is a chronic, progressive neurodegenerative condition caused by the destruction of the brain cells that produce dopamine. As the level of this chemical declines, messages from the brain telling the body how
and when to move are delivered more slowly, leaving a person incapable of initiating and controlling movements in a normal way. Azilect was approved for use as an initial single drug therapy in early Parkinson's disease, and as an addition to levodopa in more advanced patients. Levodopa is a standard treatment for Parkinson's disease. The safety and effectiveness of Azilect was demonstrated in three 18- to 26-week controlled clinical trials. One of the studies compared the effects of Azilect with the effects of placebo in 404 patients with early Parkinson's. Compared with patients on placebo, the condition of patients on Azilect showed significantly less worsening on a rating scale that measures the ability to perform mental and motor tasks as well as daily living activities. The other two studies compared the effects of Azilect with placebo when taken together with levodopa by over 1100 patients with more advanced Parkinson's. In these studies, patients using Azilect together with levodopa had significantly less time per day with relatively poor function and mobility as compared with patients on levodopa and placebo.
Azilect may be associated with hypertensive crisis if patients also consume tyramine-rich foods, beverages (such as cheese and red wine) or dietary supplements or amines contained in many cough/cold medications. Therefore, patients will need to avoid these sources of tyramine and amines when taking Azilect. As with most other medications for Parkinson's, Azilect has the potential to cause involuntary movements (dyskinesias), hallucinations and lowered blood pressure. These side effects are described in the product labeling. During development, melanoma was diagnosed in a small number of patients treated with Azilect. Although the FDA has concluded that the available data do not establish that Azilect is associated with an increased risk for melanoma, it appears that compared to the general population, patients with Parkinson's disease have an increased risk for this form of skin cancer. In order to address the question of whether or not Azilect itself increases such risk, the drug's manufacturer will perform a Phase 4 (postmarket) study. The product labeling will recommend that patients undergo periodic dermatologic examinations. Azilect is manufactured by Teva Pharmaceutical Industries in Tel Aviv, Israel.
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