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CV Therapeutics and Astellas Announce FDA Approval for Lexiscan(TM) (regadenoson) Injection
Date:4/10/2008

-First A2A Adenosine Receptor Agonist Approved for Use as Pharmacologic

Stress Agent in Myocardial Perfusion Imaging-

PALO ALTO, Calif. and DEERFIELD, Ill., April 10 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (Nasdaq: CVTX) and Astellas Pharma US, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Lexiscan(TM) (regadenoson) injection, an A2A adenosine receptor agonist, for use as a pharmacologic stress agent in radionuclide myocardial perfusion imaging (MPI) -- a test that detects and characterizes coronary artery disease -- in patients unable to undergo adequate exercise stress.

Lexiscan is the first A2A adenosine receptor agonist shown to be safe and effective as a pharmacologic stress agent in MPI studies. Lexiscan is delivered as a rapid bolus (approximately 10 seconds) with no dose adjustment required for body weight. The A2A adenosine receptor is the adenosine receptor subtype responsible for coronary vasodilation.

MPI tests, commonly called cardiac stress tests, identify areas of poor blood flow in the heart to help detect and characterize coronary artery disease, the most common type of heart disease. Many patients exercise on a treadmill to generate the increase in coronary blood flow necessary to perform an MPI study. However, almost half of the patients undergoing the 7.5 to 9.3 million 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.

"Lexiscan represents the second novel chemical entity in cardiovascular medicine th
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SOURCE Astellas Pharma US, Inc.
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