Statement from Lilly and Avid on FDA Advisory Committee Recommendation for Amyvid(TM) (Florbetapir) NDA

The U.S. Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Drugs Advisory Committee decided today that it could not recommend approval of Amyvid™ (florbetapir) at this time 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.

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.

Lilly acquired Avid Radiopharmaceuticals, Inc. in December 2010. Amyvid is Avid’s lead candidate and was the first beta-amyloid imaging compound to enter multi-center, investigational new drug (IND) clinical studies in the United States. Amyvid was recently assigned priority review designation by the FDA.

“We appreciate the careful and thoughtful review of our data today by the Committee,” said Daniel M. Skovronsky, M.D., Ph.D., CEO, Avid Radiopharmaceuticals, Inc. “We are encouraged that they recommended a clear path toward approval.”

The FDA will consider the panel’s recommendation in its review of Amyvid. The FDA takes the advice of its Advisory Committees into consideration when reviewing investigational drugs, but is not bound by their recommendations.