King Pharmaceuticals wowed an FDA advisory panel with the safety data on its new imaging drug, but failed to win over the experts with its case that the drug works as well as an approved product. The advisory panel voted 11-5 that King's studies did not demonstrate that CorVue worked as well as adenosine in widening blood vessels so that physicians could get a clear view of the heart during imaging tests.
"I had enough uncertainty that I felt more data was warranted," said Dr. Robert Harrington, a Duke University cardiologist. But others on the panel also said that the safety data on CorVue are impressive already. "The safety data are compelling ... I hope it comes back and ultimately gets marketed," said Dr. Michael Domanski.
King's CSO, Dr. Eric Carter, had tried to make the case that the imaging results for CorVue were similar to adenosine and that physicians would also find it much safer for patients. In rare cases, patients given adenosine experienced a disruption of their heart beat. But that side effect didn't appear among groups given CorVue. King's shares slid on the news of the rejection. If approved, analysts expected that CorVue would provide only about $70 million in annual revenue.
- read the Reuters report