Discover your next big idea for life sciences at PACK EXPO Las Vegas
Experience a breakthrough in life sciences packaging—explore solutions from 2,300 suppliers spanning all industries, all in one place this September

FDA Rejects Accelerated Approval for Donanemab

Regulators say Eli Lilly’s Alzheimer’s drug doesn’t have sufficient data to expedite approval, delaying commercial availability several months.

Getty Images 82633841 5e7ce34b6626f png
Getty Images

According to a recent Reuters article, the FDA rejected Eli Lilly’s application for early approval for their Alzheimer’s drug last Friday. The drug in question, donanemab, is an antibody designed to clear amyloid protein plaques from early Alzheimer’s patients’ brains. In a letter, the FDA noted that the reason is “due to the limited number of patients with at least 12 months of drug exposure data provided in the submission. In the company’s mid-stage trial, patients stopped receiving treatment after amyloid was cleared from the brain, which was around the 6 month mark for 40% of patients.

FDA warning letters surge - is your team prepared?
New guide reveals expert strategies to prevent regulatory issues and respond effectively to FDA enforcement actions in pharmaceutical and medical device manufacturing.
Read More
FDA warning letters surge - is your team prepared?
Medical Device Innovations Report
Cutting-edge packaging technologies are transforming the medical device sector in PMMI’s “Innovation in Medical Device” report, featuring advanced materials, smart solutions, and evolving regulations. Editors share insights from nearly 300 PACK EXPO booth visits—each product deemed new and truly innovative—alongside video demonstrations of the equipment and materials on display.
Learn More
Medical Device Innovations Report