FDA rejects Lilly, Avid Alzheimer's test dye

Earlier this month, Eli Lilly ($LLY) CEO John Lechleiter (photo) predicted the FDA would approve Amyvid, a new molecular imaging agent that could revolutionize Alzheimer's diagnosis by detecting the presence of amyloid plaque in the brain. Today, however, the FDA chose to accept an expert panel's recommendation and reject the drug. The agency had told Lilly to establish a training program to ensure reader accuracy and consistency of interpretations. And Lilly said it's been aware of the FDA's concerns for some time and is working to develop the necessary materials and prove the training helps avoid errors. The drug is injected into patients who are then given a PET scan to detect plaque.

Frustrated by a series of late-stage setbacks, Lilly agreed to pay up to $800 million to acquire PA-based Avid late last year. The deal included $300 million up front and up to half a billion dollars in milestones. Avid had been garnering worldwide attention for its new approach to detecting Alzheimer's.

"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."

- here's the release for more