You are here

FDA Declines to Approve Binodenoson Injection, a Heart Imaging Agent

BRISTOL, TENNESSEE, October 21, 2009 –King Pharmaceuticals, Inc. (NYSE: KG) announced today that the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding the New Drug Application (NDA) for binodenoson (CorVue) 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 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

Recent Headlines

Possible First Treatment Option for Rare Autoimmune Disease of the CNS
New Hematologic Biomarker Test Provides New Approach to Sepsis Triage and Diagnosis
Antibiotics, Statins, and Glucocorticoids All Show Promise
Current, Sole Therapy Not Always Successful/Suitable
Over 1.5 Million Americans Likely to have Wet AMD by 2020 
Potential For Use Against E. Coli, TB, Resistant Bacteria
More Than 32% of Patients Responded in Trial
Evenity Increases New Bone Formation, Lowers Vertebral Fracture Potential