CorVue is a cardiac pharmacologic stress SPECT (single-photon-emission computed tomographic) imaging agent intended for use in patients with or at risk for coronary artery disease (CAD) who are unable to perform a cardiac exercise stress test.
In the new drug application (NDA), King is requesting FDA approval of CorVue as an adjunct to non-invasive myocardial perfusion imaging tests to detect perfusion abnormalities in patients with known or suspected (CAD).
The NDA includes two Phase III clinical studies that compared CorVue, a coronary vasodilator that is a selective agonist at the adenosine A2A receptor subtype, to adenosine, a current agent of choice for pharmacologic stress testing. The studies showed that CorVue achieved the primary endpoints for efficacy and tolerability, and has an improved side effect profile compared to adenosine.
Eric Carter, chief science officer of King, said: Use of currently available agents for pharmacologic cardiac stress testing may be limited by side effects. Unlike some of these agents, CorVue targets a singular adenosine receptor subtype. As a result, CorVue was shown to produce fewer and less severe side effects than adenosine, including the risk of AV heart block, a rare but potentially serious side effect associated with adenosine-based agents.