Avid Amyvid Could Be Approved If Training Improves, Advisory Committee Says
This article was originally published in The Pink Sheet Daily
The Peripheral and Central Nervous System Drugs Advisory Committee demands a second voting question to say the data support approval of the amyloid plaque diagnostic, but not until more consistent interpretation methods are developed.
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Regulators approved the PET imaging agent for estimating neuritic plaque density in the brain despite the apparent limited clinical utility of the class.
One way or another, it is an important time in the Alzheimer’s disease space. Two potential disease altering therapies are set to divulge Phase III results that will answer important questions about the course of the illness, whether they are successful or not, and a promising cognition booster may get the Phase II readout it needs to head into a pivotal trial.
Under CMS’ current policy for PET scans, new imaging agents approved by FDA would have to go through a national coverage analysis before Medicare will pay for them.