A large majority of an FDA panel assembled to review the case for Eli Lilly's Amyvid (florbetapir) concluded that the imaging chemical for Alzheimer's isn't quite ready for approval. But if the pharma giant can set up an effective training program to show physicians how to use it--and prove that the training works--the experts say it should be approved. They voted 16-0, in fact, to recommend approval of Amyvid conditional on the training program.
Lilly wants to gain regulatory approval to use Amyvid to spotlight beta-amyloid in the brain, a condition that occurs in Alzheimer's. Significantly, the pharma company isn't trying to use it to diagnose the disease, as there's still no consensus on whether large concentrations of the protein actually trigger the illness. But panelists said physicians could be able to use Amyvid to determine if there was an absence of beta-amyloid, which could help them rule out Alzheimer's when diagnosing patients.
"Today, we don't intend this as a screening tool," said Dan Skovronsky, founder of Avid Radiopharmaceuticals, which Lilly snapped up for $300 million upfront just weeks ago. "It's not meant to be used for patients who are cognitively normal."
Added Skovronsky: "We are encouraged that they recommended a clear path toward approval."