Centocor's Myoscint Imaging Agent Backed In USA

An advisory panel to the US Food and Drug Administration has voted 8-5 in favor of recommending approval of Centocor's imaging agent Myoscint (imciromab pentetate) for patients suspected of having a myocardial infarction. Myoscint is a monoclonal antibody which reacts with heavy chain myosin following myocardial cell death.

The panel heard that Myoscint is intended to diagnose MI in patients who present with chest pain, and reviewed data which suggested that the agent offered an 84% sensitivity rate and a 97% specificity, in patients whose diagnosis was confirmed with scans. They agreed that the agent was safe and effective, but questions were raised over its clinical utility. This did not stand in the way of approval, however, as most panel members agreed that the application of the technology would become apparent with use. It would not be appropriate to ask Centocor to find these answers, they said, although this verdict did meet with some opposition.

Centocor believes that Myoscint may find a use in patients who are late presenters for suspected MI, but not for routine use. The agent is already marketed in several European countries through licensee Mallinckrodt Medical, but sales have not been significant. It is under review in Japan.