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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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Nội dung Text: Remicade và Azilect 1)
- 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.
- YDNN
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