Following the validation of MAA, the dossier is distributed to members of the Committee for Medicinal Products for Human Use (CHMP) for formal review to determine whether regadenoson is a safe and efficacious pharmacologic stress agent in humans.
Regadenoson is a selective A2A adenosine receptor agonist developed for use as a pharmacologic stress agent in MPI studies.
Regadenoson has been designed to be delivered as a rapid bolus (approximately 10 seconds) with no dose adjustment required for body weight, and to selectively stimulate the A2A adenosine receptor, the receptor responsible for coronary vasodilation.