FDA Stalls Approval of Lilly’s Alzheimer Disease Imaging Agent
Agency is asking that a reader training program be set up.
FDA followed its advisory panel’s advice from earlier this year and sent Eli Lilly a complete response letter for Amyvid™, a PET imaging agent. The NDA covered the use of the compound 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. This would help ensure reader accuracy and consistency of interpretations of existing Amyvid scans, the agency says.
In January members of FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted 13-3 to not recommend approval of Amyvid based on the currently available data. The committee unanimously voted, however, to recommend approval conditional on a reader training program that demonstrates reader accuracy and consistency through a re-read of previously acquired scans.
Since these questions were also raised by FDA reviewers late last year, Lilly and Avid say they have been working to address the issues. The companies expect to continue the dialogue with the FDA.
Eli Lilly obtained Amyvid through the $300 million acquisition of Avid Radiopharmaceuticals in November 2010. The transaction added three molecular imaging agents for detection, diagnosis, and monitoring of diseases to Lilly’s pipeline. According to the take-over agreement, Lilly agreed to pay milestones of up to $500 million linked to the success of Amyvid.
At the time of Lilly’s purchase, Amyvid was at the Phase III stage in the U.S. and subsequently received priority review from the FDA. Clinical studies are also ongoing in the EU, North and South America, Australia, and Asia.
Compounds in Avid’s pipeline that Lilly is tasked with developing include 18F-AV-133, a Phase I/II-stage agent for imaging vescular monoamine transporter (VMAT2) in disorders such as Parkinson disease and dementia with Lewy bodies, and 18F-VMAT2 PET compounds, which are designed for imaging beta cells in the pancreas as a potential approach to diagnosing beta-cell dysfunction associated with diabetes.