April 4, 2011 – The U.S. Food and Drug Administration (FDA) has given a complete response letter to Eli Lilly and its subsidiary, Avid Radiopharmaceuticals, regarding the new drug application (NDA) for Amyvid (florbetapir F 18 injection). Amyvid is a Positron Emission Tomography (PET) imaging agent under investigation for the detection of beta-amyloid plaque in the brains of living patients.
The complete response was primarily focused on the need to establish a reader training program for market implementation that helps to ensure reader accuracy and consistency of interpretations of existing Amyvid scans.
"Lilly and Avid have been engaged in an active and ongoing dialogue with the FDA," said Wei-Li Shao, Lilly brand director for Amyvid. "We remain confident in the data submission package for Amyvid."
Since questions on the reader training program were raised by FDA reviewers late last year, the companies have been working to address these questions and will continue to do so in an ongoing dialogue with the FDA.
For more information: www.lilly.com