FDA Rejects Amyvid for Alzheimers Brain Scans
As anticipated, the US Food and Drug Administration has rejected Eli Lilly’s New Drug Application (NDA) for Amyvid (florbetapir F18 injection). In January, the agency expressed concerns over the ability of the technicians to accurately read the scans when using the imaging agent.
The Peripheral and Central Nervous System Drugs Advisory Committee voted 13-3 against recommending florbetapir F18 at this time.
Amyvid is an agent intended to detect the presence of beta-amyloid plaques in the brain of Alzheimer’s patients during Positron Emission Tomography (PET) brain scans. Although there is no cure yet available for Alzheimer’s, early diagnosis may allow for important interventions to control vascular risk factors.
The safety of the drug was never in question, however, in a complete response letter to Eli Lilly, the FDA said that a reader training program must be established to ensure that scans using Amyvid are analyzed accurately before it would consider issuing marketing approval.
Eli Lilly states that they have been working on the issue since January and is confident that “active and ongoing dialogue” with the regulator will eventually lead to Amyvid’s approval.