FDA To Hold In-Person AdComm Meeting For Lilly’s Alzheimer Drug In June

FDA will hold in-person advisory committee meeting on June 10 to review the safety and efficacy implications of Eli Lilly’s high-profile Alzheimer’s drug, donanemab, based on its Phase 3 trial results. The announcement comes after FDA delayed its decision on whether to approve donanemab. FDA also issued an updated guidance on Alzheimer’s disease drug development that includes a new section emphasizing use of reduction in amyloid beta levels as a surrogate endpoint that’s predictive of clinical benefit, signaling its ongoing...