May 28, 2009
Gilead Sciences' Marketing Authorisation Application for Regadenoson Validated by European Medicines Agency
The submission includes data from two identically designed Phase III clinical trials, which showed with 95 percent confidence that MPI studies conducted with regadenoson were similar to MPI studies conducted with Adenoscan® (adenosine injection). Regadenoson was generally well tolerated in both Phase III studies. The most common adverse events reported in patients who received regadenoson were shortness of breath, headache, flushing, chest discomfort, dizziness and nausea.
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.
Regadenoson is approved by the
About Myocardial Perfusion Imaging
Myocardial perfusion imaging (MPI) tests, commonly called cardiac stress tests, identify areas of poor blood flow in the heart to help detect and characterize coronary artery disease, the most common type of heart disease. Many patients exercise on a treadmill to generate the increase in coronary blood flow necessary to perform an MPI study. However, almost half of the patients undergoing cardiac stress tests each year are unable to exercise adequately because of medical conditions. For these patients, a pharmacologic stress agent that temporarily increases blood flow through the coronary arteries is used to mimic the increase in coronary blood flow caused by exercise.
This press release includes forward-looking statements, within the
meaning of the Private Securities Litigation Reform Act of 1995, that
are subject to risks, uncertainties and other factors, including the
risks that, following its review, the CHMP will not approve regadenoson
as a pharmacologic stress agent, which may cause considerable expense
and may lead to delays or cause Gilead to abandon further development of
the product. As a result, regadenoson may never be successfully
commercialized in the
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Patrick O’Brien, 650-522-1936 (Investors)
Cara Miller, 650-522-1616 (Media)