Lilly Alzheimer's Diagnostic Expected to Get FDA Approval

01/23/2011

Lilly Alzheimer's Diagnostic Expected to Get FDA Approval

Seeking Alpha says it is only a matter of time before Eli Lilly's newly-acquired Alzheimer’s disease diagnostic, florbetapir, wins FDA approval. Lilly purchased florbetapir last November for $300 M from Avid Radiopharmaceuticals.

Florbetapir, also known as AV-45 and which Eli Lilly has branded Amyvid, is an imaging agent which binds to the characteristic beta-amyloid plaques found in the brains of Alzheimer’s patients. This essentially dyes the plaques, which can then be seen on a PET scan. Amyvid will help doctors rule out the degenerative brain disease if there is an absence of plaques.

Amyvid, and other Alzheimer’s and dementia diagnostics, will really come into their own when therapies become available and early diagnosis becomes more important, although it is possible that simpler tools will be available by then. In the meantime, with a lot of research into therapies that target beta-amyloid, Amyvid could well find an important role in clinical trials. Eli Lilly has one of the most advanced agents pursuing this avenue, solanezumab, which breaks up the beta-amyloid clumps. Amyvid should be able to track this happening.

This will be interesting to watch. The industry seems to strongly believe that companion diagnostic tests will become very important in the future with these more complex diseases in establishing treatment effectiveness or even identifying which patient classes should receive a given therapy.