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CV Therapeutics submits regadenoson

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

CV Therapeutics submits regadenoson: CV Therapeutics and Astellas submit an NDA for their novel cardiac imaging stress agent regadenoson May 14. The application is supported by two Phase III trials, which demonstrated noninferiority compared to Astellas' currently marketed stress agent Adenoscan (adenosine). CVT is highlighting a potential safety benefit for regadenoson over competing stress agents, including the market leader Adenoscan (1Pharmaceutical Approvals Monthly May 2005, p. 12). The filing triggers a $7 million payment from Astellas to CVT; upon approval CVT would receive another $12 million. CVT is also in the process of reshaping its sales force and curtailing R&D expenses to focus on a label expansion of its second-line angina drug Ranexa (ranolazine) and to launch regadenoson in mid-2008 following approval...

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