US FDA advisory gives mixed message on Eli Lilly's brain diagnostic Amyvid NDA

There was mixed news for US drug major Eli Lilly (NYSE; LLY) yesterday, when the Food and Drug Administration's Peripheral and Central Nervous System Drugs Advisory Committee decided t that it could not recommend approval of Amyvid (florbetapir) at this time based on the currently available data (13 to three).

However, the Committee voted unanimously (16-0) to recommend approval of Amyvid, an imaging agent for the detection of beta-amyloid plaque in the brain, 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.

“The information is useful, and I do think it has clinical utility,” said panel chairman Britt Anderson, a psychology professor at the University of Waterloo, adding: “But for me it's a problem that the readings thus far are significantly inconsistent.” FDA briefing papers ahead of the advisory meeting expressed similar concerns.