Astellas Launches Lexiscan(TM) (Regadenoson) Injection for Use as a Pharmacologic Stress Agent in Radionuclide Myocardial Perfus
June 24 2008 - 9:38AM
PR Newswire (US)
-First A2A Adenosine Receptor Agonist Approved for Use in
Identifying Coronary Artery Disease- DEERFIELD, Ill., June 24
/PRNewswire/ -- Astellas Pharma US, Inc. today announced the
commercial availability of Lexiscan(TM) (regadenoson) injection, an
A2A adenosine receptor agonist, for use as a pharmacologic stress
agent in radionuclide MPI -- a test that detects and characterizes
coronary artery disease -- in patients unable to undergo adequate
exercise stress. Lexiscan, co-developed with CV Therapeutics
(NASDAQ:CVTX), is the first A2A adenosine receptor agonist shown to
be safe and effective as a pharmacologic stress agent in MPI
studies. The A2A adenosine receptor subtype is primarily
responsible for coronary vasodilation. "Our clinical experience
shows that an increasing number of patients are requiring
pharmacologic stress agents for MPI studies," said Gregory Thomas,
M.D., Clinical Associate Professor of Medicine and Director of
Nuclear Cardiology Education at the University of California at
Irvine School of Medicine. "Lexiscan will be an important option in
helping to ensure proper diagnosis of coronary artery disease in
these patients." MPI tests, commonly called cardiac stress tests,
identify areas of poor blood flow in the heart to determine the
extent of coronary artery disease, a condition that affects 16
million Americans and is responsible for more than 450,000 deaths
annually in the United States. Many patients exercise on a
treadmill to generate the increase in coronary blood flow necessary
to perform an MPI study. However, almost half of patients
undergoing cardiac stress tests each year are unable to exercise
adequately because of medical conditions. For these patients, a
pharmacologic stress agent that temporarily increases blood flow
through the coronary arteries is used to mimic the increase in
coronary blood flow caused by exercise. About 7.5 to 9.3 million
MPI studies were performed last year in the U.S. Lexiscan Clinical
Trials In two identically designed Phase III clinical trials,
Lexiscan met primary endpoints for scan agreement rates by showing
with 95 percent confidence that MPI studies conducted with Lexiscan
were similar to MPI studies conducted with Adenoscan(R) (adenosine
injection). Lexiscan was generally well-tolerated in both Phase III
studies. The most common adverse events reported in patients who
received Lexiscan were shortness of breath, headache, flushing,
chest discomfort, angina or ST-segment depression, dizziness and
nausea. About Lexiscan Lexiscan is an A2A adenosine receptor
agonist approved for use as a pharmacologic stress agent in
radionuclide MPI studies in patients unable to undergo adequate
exercise stress. Lexiscan was designed to produce coronary
vasodilation and increase coronary blood flow by activation of the
A2A adenosine receptor. Lexiscan is administered as a rapid
intravenous injection (approximately 10 seconds) with no dose
adjustment required for body weight. Lexiscan should not be
administered to patients with second- or third-degree AV block or
sinus node dysfunction who do not have a functioning artificial
pacemaker. Adenosine receptor agonists, including Lexiscan, induce
arterial vasodilation and hypotension. The risk of serious
hypotension may be higher in patients with cardiac or
cerebrovascular insufficiency. Adenosine receptor agonists may
induce bronchoconstriction and respiratory compromise in patients
with COPD or asthma. Complete prescribing information for Lexiscan
is available at http://www.lexiscan.com/. About Astellas Pharma US,
Inc. Astellas Pharma US, Inc., located in Deerfield, Illinois, is a
U.S. affiliate of Tokyo-based Astellas Pharma Inc. Astellas is a
pharmaceutical company dedicated to improving the health of people
around the world through the provision of innovative and reliable
pharmaceutical products. The organization is committed to becoming
a global category leader in focused areas by combining outstanding
R&D and marketing capabilities. In the U.S., Astellas markets
products in the areas of immunology, urology, anti-infectives,
cardiovascular and dermatology. For more information about Astellas
Pharma US, Inc., please visit our Web site at
http://www.astellas.com/us. Astellas currently markets Adenoscan(R)
(adenosine injection), the leading pharmacologic stress agent for
MPI studies in the United States. Adenoscan is indicated as an
adjunct to thallium-201 myocardial perfusion scintigraphy in
patients unable to exercise adequately. The most common side
effects include flushing, chest discomfort and dyspnea. Less
frequent side effects reported in patients administered Adenoscan
include second- and third-degree AV block, fatal cardiac arrest,
ventricular tachycardia and nonfatal myocardial infarction. For
full prescribing information, please visit
http://www.adenoscan.com/. DATASOURCE: Astellas Pharma US, Inc.
CONTACT: Maribeth Landwehr of Astellas US LLC, +1-847-317-8988; or
Katherine Williams, +1-312-397-6613, for Astellas Web site:
http://www.astellas.com/ http://www.lexiscan.com/
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