Singapore, April 11, 2008: US-based CV Therapeutics and the US arm of Japanese firm Astellas Pharma have received approval from the US Food and Drug Administration for Lexiscan (regadenoson) injection for use as a pharmacologic stress agent in radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress. MPI is a test that detects and characterizes coronary artery disease.

 

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.

 

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 (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, dizziness and nausea.