CV Therapeutics and Astellas Announce FDA Approval for Lexiscan(TM) (regadenoson)...(at CV Therapeutics has received approval...)

Date:4/10/2008

at CV Therapeutics has received approval for in just over two years," stated Louis G. Lange, M.D., Ph.D., chairman and chief executive officer of CV Therapeutics. "We are very excited to have Astellas -- the clear market leader in pharmacologic stress for MPI -- commercializing Lexiscan."

"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 chief executive officer of Astellas Pharma US, Inc. "We are preparing to launch Lexiscan soon after this approval in order to provide clinicians with this important new option for patients who need pharmacologic stress agents for MPI studies."

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, 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 bolus (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 vasodilati
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SOURCE Astellas Pharma US, Inc. Copyright©2008 PR Newswire. All rights reserved

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