CV Therapeutics and Astellas Pharma have won FDA approval of Lexiscan, a A2A adenosine receptor agonist intended for use during heart stress tests. Almost half the patients undergoing cardiac stress tests are unable to exercise because of medical conditions; Lexiscan temporarily increases blood flow through the coronary arteries in order to mimic the increase in coronary blood flow caused by exercise. It works faster and has fewer side effects that Astellas' Adenoscan, the current market leader.
"We are extremely pleased that the FDA has approved Lexiscan, an exciting new option for diagnosing coronary artery disease in patients who cannot undergo an exercise stress test," said Yoshihiko Hatanaka, president and CEO of Astellas Pharma U.S. "We are preparing to launch Lexiscan soon after this approval." The approval triggersÂ $12 million to CV, and the company could earn $35 million in royalty payments in 2009.
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CV Therapeutics gains $7 million on NDA filing. CV report
CV, Astellas present positive Phase III results. CV, Astellas report