(Washington, DC) — The Food and Drug Administration will not grant accelerated approval for an experimental Alzheimer’s drug. The agency rejected Eli Lilly’s application for quick approval of the drug donanemab. That’s due to the limited number of patients who stayed on the drug for at least 12 months. The treatment has show significant promise in previous studies. The drug maker says it plans to file Phase 3 clinical trial data later this year for traditional FDA approval.
FDA Rejects Quick Approval Of Eli Lilly’s Alzheimer’s Drug
Jan 21, 2023 | 3:36 AM



