FDA Issues Complete Response Letter For CorVue™

Main Category: Cardiovascular / Cardiology
Also Included In: Heart Disease;  Regulatory Affairs / Drug Approvals
Article Date: 23 Oct 2009 - 0:00 PDT

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King Pharmaceuticals, Inc. (NYSE: KG) announced that the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding the New Drug Application (NDA) for CorVue™ (binodenoson) for injection. CorVue™ is a cardiac pharmacologic stress agent for use as an adjunct in SPECT (single-photon-emission computed tomographic) cardiac imaging intended for use in patients with or at risk for coronary artery disease (CAD) 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.

About Coronary Artery Disease

Coronary artery disease is a condition in which plaque builds up inside the coronary arteries, thereby narrowing or blocking the arteries and reducing blood flow to the heart. CAD is one of the most common forms of cardiovascular disease and is the leading cause of death globally. In the United States, it is estimated that CAD affects 16 million adults and kills more that 450,000 annually - about one in every five deaths.

About CorVue™

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.

Source
King Pharmaceuticals, Inc.