Lilly Is Confident of Amyvid FDA Approval, Lechleiter Says
Lilly Is Confident of Amyvid FDA Approval, Lechleiter Says [the Indianapolis Star]
From Indianapolis Star (IN) (March 10, 2011)
March 09--Eli Lilly & Co. Chief Executive Officer John Lechleiter said he's confident of gaining U.S. regulatory approval for a drug to help identify plaque in the brain associated with Alzheimer's disease, according to a Bloomberg News report.
Outside advisers to the Food and Drug Administration voted in January against immediate approval of the medicine, Amyvid, unless the Indianapolis-based drug maker establishes a training program and a way to ensure that results of brain scans are read consistently. Lilly aims to resolve the FDA panel's concerns in a few months, Lechleiter said in an interview in Tokyo today.
"We are confident that we can work with the FDA and gain approval," Lechleiter, 57, said in the Bloomberg report. "This is an imaging agent that we've used in our own clinical studies, so we are very familiar with it."
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Posted: March 2011