Navigation Links
Astellas Launches Lexiscan(TM) (Regadenoson) Injection for Use as a Pharmacologic Stress Agent in Radionuclide Myocardial Perfusion Imaging (MPI)
Date:6/24/2008

-First A2A Adenosine Receptor Agonist Approved for Use in Identifying

Coronary Artery Disease-

DEERFIELD, Ill., June 24 /PRNewswire/ -- Astellas Pharma US, Inc. today announced the commercial availability of Lexiscan(TM) (regadenoson) injection, an A2A adenosine receptor agonist, for use as a pharmacologic stress agent in radionuclide MPI -- a test that detects and characterizes coronary artery disease -- in patients unable to undergo adequate exercise stress. Lexiscan, co-developed with CV Therapeutics (Nasdaq: CVTX), is the first A2A adenosine receptor agonist shown to be safe and effective as a pharmacologic stress agent in MPI studies. The A2A adenosine receptor subtype is primarily responsible for coronary vasodilation.

"Our clinical experience shows that an increasing number of patients are requiring pharmacologic stress agents for MPI studies," said Gregory Thomas, M.D., Clinical Associate Professor of Medicine and Director of Nuclear Cardiology Education at the University of California at Irvine School of Medicine. "Lexiscan will be an important option in helping to ensure proper diagnosis of coronary artery disease in these patients."

MPI tests, commonly called cardiac stress tests, identify areas of poor blood flow in the heart to determine the extent of coronary artery disease, a condition that affects 16 million Americans and is responsible for more than 450,000 deaths annually in the United States. Many patients exercise on a treadmill to generate the increase in coronary blood flow necessary to perform an MPI study. However, almost half of 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. About 7.5 to 9.3 million MPI studies were performed last year in the U.S.

Lexiscan Clinical Trials

In two identically designed Phase III clinical trials, Lexiscan met primary endpoints for scan agreement rates by showing with 95 percent confidence that MPI studies conducted with Lexiscan were similar to MPI studies conducted with Adenoscan(R) (adenosine injection).

Lexiscan was generally well-tolerated in both Phase III studies. The most common adverse events reported in patients who received Lexiscan were shortness of breath, headache, flushing, chest discomfort, angina or ST-segment depression, dizziness and nausea.

About Lexiscan

Lexiscan is an A2A adenosine receptor agonist approved for use as a pharmacologic stress agent in radionuclide MPI studies in patients unable to undergo adequate exercise stress. Lexiscan was designed to produce coronary vasodilation and increase coronary blood flow by activation of the A2A adenosine receptor. Lexiscan is administered as a rapid intravenous injection (approximately 10 seconds) with no dose adjustment required for body weight. Lexiscan should not be administered to patients with second- or third-degree AV block or sinus node dysfunction who do not have a functioning artificial pacemaker. Adenosine receptor agonists, including Lexiscan, induce arterial vasodilation and hypotension. The risk of serious hypotension may be higher in patients with cardiac or cerebrovascular insufficiency. Adenosine receptor agonists may induce bronchoconstriction and respiratory compromise in patients with COPD or asthma. Complete prescribing information for Lexiscan is available at http://www.Lexiscan.com.

About Astellas Pharma US, Inc.

Astellas Pharma US, Inc., located in Deerfield, Illinois, is a U.S. affiliate of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. The organization is committed to becoming a global category leader in focused areas by combining outstanding R&D and marketing capabilities. In the U.S., Astellas markets products in the areas of immunology, urology, anti-infectives, cardiovascular and dermatology. For more information about Astellas Pharma US, Inc., please visit our Web site at http://www.astellas.com/us.

Astellas currently markets Adenoscan(R) (adenosine injection), the leading pharmacologic stress agent for MPI studies in the United States. Adenoscan is indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately. The most common side effects include flushing, chest discomfort and dyspnea. Less frequent side effects reported in patients administered Adenoscan include second- and third-degree AV block, fatal cardiac arrest, ventricular tachycardia and nonfatal myocardial infarction. For full prescribing information, please visit http://www.adenoscan.com.


'/>"/>
SOURCE Astellas Pharma US, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. CV Therapeutics and Astellas Announce FDA Approval for Lexiscan(TM) (regadenoson) Injection
2. Astellas and Boehringer Ingelheim Reach Settlement Agreement with Ranbaxy on Flomax Patent Case
3. Astellas Pharma US, Inc. and The International Transplant Nurses Society (ITNS) Collaborate on Content for Transplant Experience Program
4. Astellas and Theravance Report Additional Telavancin Data at 47th Annual ICAAC
5. Pharsight Launches PK Accelerator(TM)
6. IS Clinical Launches New ADVANCE+ Skincare Line
7. EH&E Launches Interactive Discussion Forum for Healthcare Environment of Care Professionals
8. BioSpace Launches EuroBio(TM) Online Community
9. NanoInterventions Launches New, Rapid Testing System for Coronary Stents
10. Thomson Reuters Launches New Biomarkers Solution
11. Cardiac Science Launches Anywhere Data Management for HIS and EMR Systems
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/17/2017)... Jan. 17, 2017   Pulmatrix, Inc . (NASDAQ: ... developing innovative inhaled therapies to address serious pulmonary diseases, ... infections in the lungs of CF patients, PUR1900, has ... by the U.S. Food & Drug Administration. ... to speed the development of novel drugs against important ...
(Date:1/17/2017)...  Only nine percent of U.S. consumers believe pharmaceutical ... 16 percent believe health insurance companies do, according to ... of U.S. adults believe health care providers (such as ... hospitals (23%). "We are in the midst ... , vice president of reputation management and public affairs ...
(Date:1/17/2017)... (PRWEB) , ... January 17, 2017 , ... Pono ... balanced, peaceful and healthy lifestyle, announced today the official launch of its much-anticipated Pono ... the mind. , In development for over a year, the patented Pono ...
(Date:1/17/2017)... ... January 17, 2017 , ... Diagenode, ... recently announced a collaboration with the Heidelberg University Hospital and the German Cancer ... preparation, following the company’s successful launch of its CATS (Capture and Amplification ...
Breaking Biology Technology:
(Date:12/16/2016)... -- Research and Markets has announced the addition of ... 2021" report to their offering. ... The biometric vehicle access system market, in ... 14.06% from 2016 to 2021. The market is estimated to be ... Million by 2021. The growth of the biometric vehicle access system ...
(Date:12/15/2016)... , Dec 15, 2016 ... Research and Markets has announced the addition ... offering. The report forecasts the global military biometrics market ... The report has been prepared based on an in-depth market ... and its growth prospects over the coming years. The report also includes ...
(Date:12/12/2016)... -- Researchers at Trinity College, Dublin, are opening up ... material with Silly Putty. The mixture (known as "G-putty") ... sense pulse, blood pressure, respiration, and even the ... The research team,s findings were published Thursday in ... Due ...
Breaking Biology News(10 mins):