Adenosine Agonist for Stress Perfusion Imaging Approved

April 15, 2008

April 15, 2008 (Palo Alto, CA and Deerfield, IL) - The US Food and Drug Administration has market-approved regadenoson (Lexiscan), a selective A2A adenosine-receptor agonist, for resting stress-myocardial perfusion scans, the product's developer and owner CV Therapeutics and marketer-distributor Astellas Pharma US have jointly announced [1].

Lexiscan was approved based on two identical phase 3 trials [2] in which the agent produced perfusion scans of similar quality to those made using another Astellas product, adenosine injection (Adenoscan), according to the announcement. Lexiscan is administered as a non–weight-adjusted rapid bolus, which, published reports observe, is a less complicated regimen than what is required for adenosine; it's also expected to have a more favorable side-effect profile by virtue of its adenosine-receptor selectivity.

  1. CV Therapeutics. CV Therapeutics and Astellas announce FDA approval for Lexiscan (regadenoson) injection [press release]. April 10, 2008. Available at: http://www.cvt.com/PressRelease.aspx?releaseID=1128317 .

  2. Iskandrian AE, Bateman TM, Belardinelli L, et al. ADVANCE MPI Investigators. Adenosine versus regadenoson comparative evaluation in myocardial perfusion imaging: Results of the ADVANCE phase 3 multicenter international trial. J Nucl Cardiol 2007; 14:645-658. Abstract

The complete contents of Heartwire , a professional news service of WebMD, can be found at www.theheart.org, a Web site for cardiovascular healthcare professionals.



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