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.
SOURCE Astellas Pharma US, Inc.