The FDA Peripheral and Central Nervous System Drugs Advisory Committee decided Jan. 20 that it could not recommend approval of florbetapir (Amyvid, Eli Lilly) based on the currently available data (13-3); but voted unanimously (16-0) to recommend approval of Amyvid conditional on a reader training program that demonstrates reader accuracy and consistency through a re-read of previously acquired scans.
The committee supported that efficacy was established and there were no significant safety concerns raised, according to the Indianapolis-based company.
Amyvid is a molecular imaging compound for PET under investigation for the detection of beta-amyloid plaque in the brain. The committee stated that a negative scan would be clinically useful in indicating that Alzheimer's pathology is unlikely to be the cause of a patient's cognitive decline.
Earlier this week, research published in the Journal of the American Medical Association found a strong quantitative correlation between the biomarker florbetapir F18's signal on PET scans and the presence of beta-amyloid in the brain at death, further supporting mounting evidence that imaging biomarkers may be applied for diagnosing and determining early risks for Alzheimer's disease.
Lilly acquired Avid Radiopharmaceuticals, which developed Amyvid, in December 2010. Amyvid was the first beta-amyloid imaging compound to enter multicenter, investigational new drug clinical studies in the U.S. Amyvid was recently assigned priority review designation by the FDA.
The FDA takes the advice of its advisory committees into consideration when reviewing investigational drugs, but is not bound by their recommendations.