FDA Pauses Eli Lilly Alzheimer's Drug Approval, Cites Need to Review Safety
• FDA delays approval of Eli Lilly's Alzheimer's drug donanemab, calling for an advisory committee meeting to review safety and efficacy
• Move surprises Lilly, as FDA had set an anticipated approval date already
• Donanemab targets amyloid beta plaque in the brain, but benefit is small - only slows cognitive decline
• Two other Alzheimer's drugs recently approved also faced similar scrutiny over brain bleeding risks
• Logistical constraints likely mean limited launch and modest earnings impact initially if approved