FDA approves cardiac imaging agent from CV Therapeutics, Astellas

The FDA has approved Lexiscan (regadenoson) injection, an A2A adenosine receptor agonist developed by CV Therapeutics and marketed by Astellas Pharma U.S., for use as a pharmacologic stress agent for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress.

Lexiscan is the first A2A adenosine receptor agonist shown to be safe and effective as a pharmacologic stress agent in MPI studies, according to the Deerfield, Ill.-based Astellas and the Palo Alto, Calif.-based CV Therapeutics.

Lexiscan is delivered as a rapid bolus (about 10 seconds) with no dose adjustment required for body weight, the companies said. The A2A adenosine receptor is a subtype responsible for coronary vasodilation.

“Lexiscan represents the second novel chemical entity in cardiovascular medicine that CV Therapeutics has received approval for in just over two years,” said Louis G. Lange, MD, PhD, chairman and CEO of CV Therapeutics. Astellas will be responsible for commercializing Lexiscan.

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, according to the companies.

Adenoscan is also marketed by Astellas, but was manufactured by the Lake Forest, Ill.-based Hospira.