FDA Panel Suggests Conditional Approval for Lilly Imaging Agent

An FDA advisory committee said an Eli Lilly contrast agent that may be useful in predicting Alzheimer’s disease could be approved if the company conducts physician training to make sure brain scans are read consistently. Although the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted 13–3 that the imaging agent, known as Amyvid (florbetapir F 18 injection), could not be approved based on currently available data, the panel unanimously recommended it could be conditionally approved if Lilly establishes a reader training program to ensure accuracy of scan reads.
Washington Drug Letter