Lilly’s Donanemab: US FDA's Questions Focus On Patient Selection, Dose Cessation

 
• By Sue Sutter

Given the frequent occurrence of ARIA and an imbalance of deaths in the pivotal TRAILBLAZER-ALZ 2 study, the agency also will ask the Peripheral and Central Nervous System Drugs Advisory Committee whether there are patient subgroups where the benefit-risk is more or less favorable.

Stop sign
An advisory committee will consider how the donanemab Phase III trial's treatment-stopping rules should translate to clinical practice. • Source: Shutterstock

More from US FDA Performance Tracker

More from Regulatory Trackers