CV Therapeutics and Astellas Pharma have announced that the second of two Phase 3 clinical studies of regadenoson met its primary endpoint. A prior identically designed Phase 3 study, completed in 2005, also met its primary endpoint. Regadenoson is used in myocardial perfusion imaging studies. "With two identically designed Phase 3 studies having hit their primary endpoints, we are excited about the opportunity to pursue approval of regadenoson. We are also pleased that regadenoson once again demonstrated safety and tolerability," said Louis G. Lange, M.D., Ph.D., chairman and chief executive officer of CV Therapeutics. Based on the results of these two Phase 3 clinical trials, CV Therapeutics plans to submit an NDA to the FDA in mid-2007.
- for more, see this press release