Eli Lilly & Co.’s drug to help identify plaque in the brain tied to Alzheimer’s disease can’t be approved unless the company establishes a training program and a way to ensure that results of brain scans are read consistently, a U.S. panel said.
Outside advisers to the Food and Drug Administration voted 13-3 yesterday against immediate approval of the medicine, Amyvid, at a meeting in Silver Spring, Maryland. The panel then unanimously recommended the drug may be cleared for sale to detect beta-amyloid plaque deposits if those conditions are met. The FDA usually follows the recommendations of its advisory panels though it isn’t required to do so.
Lilly, based in Indianapolis, acquired Amyvid in its $300 million purchase of closely held Avid Radiopharmaceuticals in December. The acquisition hasn’t been viewed by investors as important to Lilly’s broader focus on replacing top products before their patents expire.
“We appreciate the careful and thoughtful review of our data today by the committee,” said Daniel M. Skovronsky, chief executive officer of Lilly’s Avid subsidiary, in a statement. “We are encouraged that they recommended a clear path toward approval.”
While injections of Amyvid, known chemically as florbetapir, seem to detect beta-amyloid plaque deposits, this hasn’t been shown to be clinically useful, FDA staff said in a report released Jan. 18. The agency has “major concerns” about the lack of standardized tools to decipher the results of brain scans and their significance to patient health, the staff said.
Alzheimer’s disease is the most common form of dementia among older people, affecting as many as 5.1 million Americans according to the National Institutes of Health. While doctors use brain scans and mental exercises to determine when a patient may have the disease, a definitive diagnosis can be made only through an autopsy after death.
“People have amyloid in the brain who clearly don’t have Alzheimer’s disease,” Skovronsky said in a Jan. 18 interview. “Does that mean they’re going to get Alzheimer’s? Maybe. We just don’t yet.”
Lilly gained 1 cent to $34.76 at 4 p.m. in New York Stock Exchange composite trading.
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