Donanemab FDA Approval Status
Last updated by Judith Stewart, BPharm on March 11, 2024.
FDA Approved: No
Generic name: donanemab
Company: Eli Lilly and Company
Treatment for: Alzheimer's Disease
Donanemab is an antibody therapy that targets a modified form of deposited amyloid-β peptide called N3pG in development for the treatment of early Alzheimer's disease.
- Alzheimer’s disease is an illness that causes progressive decline in memory and other aspects of cognition. It is thought to be caused by the accumulation of amyloid-β (Aβ) peptide in the form of amyloid plaques.
- Donanemab is a humanized IgG1 antibody directed at an N-terminal pyroglutamate Aβ epitope that is present only in established plaques. In a phase 1b study, involving patients with amyloid-positive mild cognitive impairment or mild-to-moderate Alzheimer’s disease with dementia, donanemab reduced the amyloid plaque level as measured by the uptake of 18F-florbetapir tracer on positron-emission tomography (PET), even after a single dose.
- In January 2023, the U.S. Food and Drug Administration (FDA) issued a complete response letter for the accelerated approval 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. The FDA specifically requested that Lilly provide data from at least 100 patients who received a minimum of 12 months of continued treatment on donanemab. While the trial included more than 100 patients treated with donanemab, due to the speed of plaque reduction, many patients were able to stop dosing as early as 6 months of treatment, resulting in fewer than 100 patients receiving 12 months of donanemab. The FDA indicated that the data to meet the exposure expectation would likely need to include the unblinded controlled safety data from TRAILBLAZER-ALZ 2 upon completion.
- In March 2024, it was announced that the FDA expects to convene a meeting of the Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) to further understand topics related to evaluating the safety and efficacy of donanemab, and the implications of the unique trial design of the TRAILBLAZER-ALZ 2 study, including its limited-duration dosing regimen that allowed patients to complete treatment based on an assessment of amyloid plaque and the inclusion of participants based on tau levels. The date of the advisory committee meeting for donanemab has yet to be set by the FDA, and, as a result, the timing of expected FDA action on donanemab will be delayed beyond the first quarter of 2024.
Development timeline for donanemab
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