October 21, 2009 – King Pharmaceuticals Inc. said today the U.S. Food and Drug Administration issued a complete response letter regarding the new drug application (NDA) for its cardiac pharmacologic stress agent CorVue (binodenoson), and the company is working on a response.
CorVue is an injectable cardiac pharmacologic stress agent for use as an adjunct in SPECT (single-photon-emission computed tomographic) perfusion imaging. It is intended for use in patients with or at risk for coronary artery disease who are unable to perform a cardiac exercise stress test.
King is currently evaluating the FDA’s complete response letter and expects to respond to the agency’s questions as quickly as possible.
CorVue, a selective adenosine A2A receptor agonist, is being developed as an alternative to exercise prior to cardiac perfusion imaging for the diagnosis of coronary artery disease. CorVue is designed to minimize side effects such as dyspnea, flushing, heart block and chest pain. For ease of administration, CorVue is being developed for dosing as a single IV injection. CorVue has a fast onset while providing a sufficient duration of coronary blood vessel dilation for flexibility in diagnostic imaging.
For more information: www.kingpharm.com