19 January 2023 - Complete response letter based on limited number of patients with 12 month drug exposure data in the accelerated approval submission; no other deficiencies were identified.

Eli Lilly today announced the US FDA has issued a complete response letter for the accelerated approval submission of donanemab for the treatment of early symptomatic Alzheimer's disease due to the limited number of patients with at least 12 months of drug exposure data provided in the submission.

Read Eli Lilly press release