Imaging Agent Approved for Detection of Alzheimer's Plaques

 

 April 9, 2012 — The US Food and Drug Administration (FDA) has approved the imaging agent florbetapir F 18 injection (Amyvid, Lilly) to detect beta-amyloid plaques in living patients with cognitive impairment who are being evaluated for Alzheimer's disease and other causes of cognitive decline.

Eli Lilly and Company and Avid Radiopharmaceuticals announced the approval in a statement.

"The approval of Amyvid offers physicians a tool that, in conjunction with other diagnostic evaluations, can provide information to help physicians evaluate their patients," Daniel Skovronsky, MD, PhD, president and CEO of Avid and global brand development leader for Amyvid at Lilly, said in a release.

In January 2011, an FDA advisory committee recommended against approval of the agent in an unequivocal 13 to 3 vote. However, in a second unofficial vote, the same committee voted 16 to 0 in favor of approval of florbetapir if the company were to improve education initiatives for readers of these images.

The first ligand developed and widely used for amyloid imaging was carbon 11–labeled Pittsburgh compound B (C-PiB). However, with a short half-life of 20 minutes, use of this agent was limited to specialized treatment centers that have the capacity to manufacture the agent.

Florbetapir has a half-life of almost 2 hours, allowing it to be transported to treatment centers away from manufacturing facilities.

The company reports that beginning in June, a limited number of radiopharmacies will be distributing Amyvid, with the goal of making the product available in more areas as soon as possible.

"We are working hard with our manufacturing partners to increase production of Amyvid and will notify the community as it becomes available in more markets."

The company reports that it has been working with the "FDA and nuclear medicine experts to identify the appropriate ways to support accurate and consistent interpretation of Amyvid scans by imaging physicians. These efforts resulted in the development and validation by Lilly of both an online and in-person reader training program for physicians using Amyvid. Errors may occur in the estimation of plaque density during image interpretation."