CV Therapeutics, Inc. and Astellas Pharma US Inc.


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CV Therapeutics, Inc. and Astellas Pharma US Inc. 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.