CV Therapeutics Submits New Drug Application For Regadenoson
CV Therapeutics, Inc. and Astellas Pharma US, Inc. announced that CV Therapeutics has submitted a new drug application (NDA) to the U.S. food and Drug Administration (FDA) seeking approval of regadenoson for use in myocardial perfusion imaging (MPI) studies. The NDA submission triggers a $7 million milestone payment from Astellas to CV Therapeutics.
Regadenoson is a selective A2A-adenosine receptor agonist under development for use as a pharmacologic stress agent in MPI studies. Regadenoson has been designed to be delivered as a rapid bolus with no dose adjustment required by weight, and to selectively stimulate the A2A-adenosine receptor, the receptor responsible for coronary vasodilation.
If regadenoson is approved by the FDA, Astellas Pharma US, Inc. will be responsible for all commercial activities for regadenoson in the United States. CV Therapeutics retains all rights to regadenoson outside of North America.
The NDA contains data from two identically designed Phase 3 clinical trials. In both Phase 3 trials, regadenoson met the primary endpoint by showing with 95 percent confidence that MPI studies conducted with regadenoson were comparable to MPI studies conducted with Adenoscan(R) (adenosine injection).
According to the company, Regadenoson was generally well tolerated in both Phase 3 studies. The most common adverse events reported in patients who received regadenoson were shortness of breath, headache, flushing, chest discomfort and dizziness.
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