ANALIZE MEDICALE DE LABORATOR
Aici gasiti analizele medicale grupate pe categorii precum si detalii generale si specifice pentru categoriile respective.
Selectati o categorie din lista de mai jos:
Solutie antistress!
Construieste poduri :)
Prinde pisica neagra :)
FDA Advisory Committee Recommends Approval Of Exelon(R) (rivastigmine Tartrate) In The Treatment Of Dementia Associated With Parkinson's Disease
Novartis announced that
Exelon (rivastigmine tartrate) received a favorable opinion from the
Peripheral and Central Nervous System Drugs Advisory Committee of the U.S.
Food and Drug Administration (FDA) for the treatment of mild to moderate
dementia associated with Parkinson's disease.
If approved, Exelon would be the first and only medication available
for the treatment of dementia associated with Parkinson's disease. Exelon
is currently approved for the treatment of mild to moderate Alzheimer's
disease.
About 40% of patients with Parkinson's disease are estimated to also
develop dementia, which can have a devastating effect on patients and their
families. The risk for developing dementia among Parkinson's patients is
approximately four to six times higher than among elderly people without
this disease. No approved medications are available to treat dementia in
Parkinson's patients.
"We are very pleased with the Advisory Committee's recommendation in
support of the efficacy and safety of Exelon for the treatment of dementia
associated with Parkinson's disease," said Alex Gorsky, Head of Pharma
North America and CEO, Novartis Pharmaceuticals Corporation. "Novartis is
committed to developing therapies to help patients with dementia and their
caregivers. We will continue to work closely with the FDA as the Agency
finalizes its review of Exelon for the treatment of Parkinson's patients
with dementia."
The FDA Advisory Committee's recommendation will be considered by the
FDA in making its decision regarding the sNDA for Exelon capsules for the
treatment of dementia associated with Parkinson's disease, which is
expected during the third quarter of this year. The committee's
recommendation was based on a review of results from the EXelon in
PaRkinson's disEaSe dementia Study (EXPRESS). EXPRESS is the first
large-scale, prospective, randomized, double-blind, placebo-controlled,
multicenter study with an Alzheimer's disease medication to demonstrate
statistically significant improvement in the treatment of symptoms of
dementia associated with Parkinson's disease.
Published in the New England Journal of Medicine in December 2004,
EXPRESS included 541 patients and is the first and only prospective,
large-scale trial to show benefits in patients with dementia associated
with PD. The outcomes were better in patients treated with Exelon compared
to placebo (sugar pill) in both the primary and secondary variables. There
was statistically significant improvement in overall functioning in
patients treated with Exelon relative to deterioration seen in those
treated with placebo, in cognition and certain aspects of behavior.
Patients treated with Exelon also had less deterioration in their ability
to perform activities of daily living than patients who received placebo.
Patients enrolled in the study had mild to moderate dementia, which
developed at least two years after they were diagnosed with Parkinson's
disease.
Exelon was generally well tolerated. The most frequent side effects
associated with Exelon were nausea and vomiting, which were mild to
moderate in nature. More patients treated with Exelon reported increased
tremor than did patients on placebo, but this rarely resulted in withdrawal
from the study and the rating scale used to measure motor function in
Parkinson's disease (UPDRS III) did not show a significant deterioration
relative to baseline nor a statistically significant increase in tremor
between Exelon and placebo.
In March 2006, Exelon was granted European marketing authorization for
the treatment of dementia associated with Parkinson's disease in all 25
European member states, making it the only medication available to treat
dementia associated with Parkinson's in the European Union. In addition to
the EU, Exelon has also been approved to treat dementia associated with
Parkinson's disease in 14 other countries around the world.
Additional Information
Parkinson's disease is a chronic and progressive disease of the nervous
system. According to the National Parkinson Foundation, Parkinson's disease
affects 1.5 million Americans and dementia is one of the complications most
feared by Parkinson's disease patients. In addition to cognitive
impairment, neuro-psychiatric symptoms (e.g., depression, hallucinations,
anxiety and apathy) are also common. These symptoms impact the patient's
quality of life, course of the disease and caregiver distress.
As with Alzheimer's disease, dementia in Parkinson's disease patients
is associated with a cholinergic deficit, which results in decreased
transmission of signals between nerves in the brain, especially those that
rely on the neurotransmitter acetylcholine. This deficit contributes to the
cognitive and behavioral problems observed in these patients.
Safety Information About Exelon
Exelon is approved for mild to moderate Alzheimer's disease. It has
been administered to over 3 million patients worldwide and is cleared for
marketing in over 70 countries.
Exelon use is associated with significant stomach-related side effects,
including nausea, vomiting, loss of appetite, and weight loss. If therapy
is interrupted for longer than several days, treatment should be
reinitiated with the lowest daily dose in order to avoid the possibility of
severe vomiting and its potentially serious consequences
.
In clinical studies, stomach-related side effects occurred more
frequently as doses were increased. The weight loss associated with Exelon
occurred more commonly among women receiving high doses in clinical
studies. Because these side effects can be serious, caregivers should be
encouraged to monitor for these adverse events and inform the physician if
they occur. People at risk for certain heart conditions or stomach ulcers
should notify their doctor before starting Exelon therapy. In clinical
studies, some patients also experienced fainting, weakness, and upset
stomach. For more information, please see complete prescribing information
at http://www.Exelon.com.
The foregoing press release contains forward-looking statements that
can be identified by forward-looking terminology, such as "if approved",
"would be", and "can have", or implied statements regarding potential
future approvals of, or potential future revenues from Exelon. Such
statements involve known and unknown risks, uncertainties and other factors
that may cause the actual results to be materially different from any
future results, performance, or achievements expressed or implied by such
statements. There can be no guarantee that Exelon will reach any particular
sales levels. In particular, management's expectation regarding the
commercial success of Exelon could be affected by among other things,
uncertainties relating to product development, regulatory actions or delays
or government regulation generally, the ability to obtain or maintain
patent or other proprietary intellectual property protection and
competition in general, as well as factors discussed in the Form 20F filed
with the Securities and Exchange Commission. Should one or more of these
risks or uncertainties materialize, or should underlying assumptions prove
incorrect, actual results may vary materially from those described herein
anticipated, believed, estimated or expected. Novartis is providing the
information in this press release as of this date and does not undertake
any obligation to update any forward-looking statements contained in this
press release as a result of new information, future events or otherwise.
About Novartis
Novartis Pharmaceuticals Corporation develops, manufactures, markets
and sells leading innovative prescription drugs used to treat a number of
diseases and conditions, including those in the cardiovascular, metabolic,
cancer, organ transplantation, central nervous system, dermatological,
gastrointestinal and respiratory areas. The company's mission is to improve
people's lives by pioneering novel healthcare solutions.
Novartis has been a leader in the neuroscience area for more than 50
years, having pioneered early breakthrough treatments for Alzheimer's
disease, Parkinson's disease, Attention Deficit Hyperactivity Disorder,
epilepsy, schizophrenia and migraine, many of which continue to be regarded
as "gold standards" to this day. Novartis Neuroscience continues to be at
the forefront of research and development of new compounds, is committed to
addressing unmet medical needs and to supporting patients and families
affected by these disorders.
Located in East Hanover, New Jersey, Novartis Pharmaceuticals
Corporation is an affiliate of Novartis AG (NYSE: NVS) -- a world leader in
offering medicines to protect health, treat disease and improve well-being.
Our goal is to discover, develop and successfully market innovative
products to treat patients, ease suffering and enhance the quality of life.
Novartis is the only company with leadership positions in both patented and
generic pharmaceuticals. We are strengthening our medicine-based portfolio,
which is focused on strategic growth platforms in innovation-driven
pharmaceuticals, high-quality and low-cost generics and leading
self-medication OTC brands. In 2005, the Group's businesses achieved net
sales of USD 32.2 billion and net income of USD 6.1 billion. Approximately
USD 4.8 billion was invested in R&D. Headquartered in Basel, Switzerland,
Novartis Group companies employ approximately 91,000 people and operate in
over 140 countries around the world. For more information, please visit
http://www.novartis.com.
Novartis
http://www.Exelon.com/
View drug information on Exelon.
FDA Comitetul consultativ recomandã Aprobarea Exelon (R) (rivastigmine tartrat) în tratamentul demenþã asociatã cu boala Parkinson - FDA Advisory Committee Recommends Approval Of Exelon(R) (rivastigmine Tartrate) In The Treatment Of Dementia Associated With Parkinson's Disease - articole medicale engleza - startsanatate