Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Gilead Sciences has announced that the Marketing Authorisation Application (MAA) for regadenoson, an investigational pharmacologic stress agent for radionuclide myocardial perfusion imaging (MPI), was validated by the European Medicines Agency (EMEA).
Subscribe to our email newsletter
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.