King submits NDA for cardiac stress SPECT agent
King Pharmaceuticals has submitted a new drug application (NDA) to the FDA for CorVue, a cardiac pharmacologic stress SPECT imaging agent intended for use in patients with or at risk for coronary artery disease (CAD) who are unable to undergo a cardiac exercise stress test.
In the NDA, the Bristol, Tenn.-based King said it 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. Targeting the A2A receptor may result in fewer side effects, King said.
The company said that vasodilator pharmacologic stress agents work by stimulating adenosine receptors in the coronary vasculature.
In the NDA, the Bristol, Tenn.-based King said it 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. Targeting the A2A receptor may result in fewer side effects, King said.
The company said that vasodilator pharmacologic stress agents work by stimulating adenosine receptors in the coronary vasculature.