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news.CV Therapeutics and Astellas Pharma have said that the second of two phase III clinical studies of the cardiovascular drug regadenoson met its primary endpoint.
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Regadenoson is a selective A2A-adenosine receptor agonist for potential use as a pharmacologic stress agent in myocardial perfusion imaging (MPI) studies.
A prior identically designed phase III study, completed in 2005, also met its primary endpoint. Based on the results of these two phase III clinical trials CV Therapeutics plans to submit a new drug application to the FDA in mid-2007.
If regadenoson is approved by the FDA, Astellas Pharma will be responsible for all commercial activities for regadenoson in the US. CV Therapeutics retains all rights to regadenoson outside of North America.
In this study, regadenoson met its primary endpoint by showing with 95% confidence that MPI studies conducted with regadenoson were comparable to MPI studies conducted with adenoscan.
“The need for myocardial perfusion imaging tests as a diagnostic aid continues to increase in the US,” said Yoshihiko Hatanaka, president and CEO of Astellas Pharma.