Innovative Trial Design may have Cost Lilly’s Donanemab Accelerated Approval

Lilly sought accelerated approval for the investigational antibody based on findings from the Phase II TRAILBLAZER-ALZ trial, which enrolled more than 100 participants but allowed patients to end treatment when amyloid plaques had been cleared past a certain pre-defined level. As a result of the study’s design, fewer than 100 patients were on donanemab for 12 continuous months.