King Pharmaceuticals, Inc announced that the US 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.
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.