Eli Lilly & Co. (LLY) Thursday said the U.S. Food and Drug Administration's Peripheral and Central Nervous System Drugs Advisory Committee decided that it could not recommend approval of Amyvid or florbetapir at this time based on the currently available data. However, it voted 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.
Amyvid is a molecular imaging tool 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. Amyvid was recently assigned priority review designation by the FDA.
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June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.