The U.S. Food and Drug Administration on October 25 approved a second amyloid imaging agent. Flutemetamol is an F18-labeled ligand developed by GE Healthcare. It joins florbetapir, developed by Avid Pharmaceuticals/Eli Lilly and Company.

Flutemetamol differs slightly from its cousin because it is approved to report the intensity of binding to amyloid plaques in false color. This could make scans easier to read, some experts agreed. The compound will be commercially available in early 2014.

In regulatory terms, both are approved to indicate whether amyloid is present, and thereby support or refute an AD diagnosis. Neither is intended to diagnose AD on its own or replace other routine clinical tests for cognitive decline. Neither compound is approved to quantify amyloid plaques in the brain. That is something both companies are exploring.

Both agents will be made available to both neurologists and researchers. GE Healthcare has submitted an application for approval to the European Medicines Agency (EMA), and will apply in various other countries in the coming months and years. Florbetapir has already gotten EMA approval, and Lilly/Avid is seeking approval in other areas of the world.

Source:  AlzForum website – 21 Nov 2013



November 22, 2013