Lilly CEO confident in FDA approval
Eli Lilly CEO 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 FDA voted in January against immediate approval of the medicine, Amyvid, unless the Indianapolis-based drug maker established 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.
"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."