FDA sets June advisory panel meeting on donanemab clinical trial

Central nervous system committee will meet June 10

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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A U.S. Food and Drug Administration (FDA) advisory committee will meet June 10 to review clinical trial data related to donanemab, Eli Lilly‘s experimental anti-amyloid therapy, according to a company press release.

The FDA is reviewing Lilly’s application seeking approval of donanemab to treat early Alzheimer’s disease. Lilly announced in March that the FDA would hold a meeting of its Central Nervous System Drugs Advisory Committee, an unexpected step that delayed the review of Lilly’s application. The company applied for approval of donanemab last year, and results were initially expected before the start of 2024.

Lilly’s application is based mainly on data from a Phase 3 clinical trial called TRAILBLAZER-ALZ 2 (NCT04437511), which tested donanemab against a placebo in more than 1,100 people with early Alzheimer’s. Results showed that, after 18 months, patients on donanemab showed significantly less decline on an array of cognitive and functional measures.

The effects of donanemab were more dramatic among patients who were younger and had less substantial cognitive impairment at the trial’s start. The medication’s most common side effects were amyloid-related imaging abnormalities (ARIA), which are marked by swelling and/or bleeding in the brain.

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Advisory panel to review trial in detail

ARIA is a well-established side effect of anti-amyloid therapies like donanemab, which are designed to break up toxic clumps of the protein beta-amyloid in the brain. Beta-amyloid aggregates are a molecular hallmark of Alzheimer’s and are thought to play a central role in disease progression.

Most cases of ARIA in patients on donanemab in TRAILBLAZER-ALZ 2 were not serious, but a few were life-threatening. Among patients on donanemab, 1.6% experienced severe ARIA, including three cases linked to death.

In the June meeting, a group of experts will go through data from the trial in detail. Lilly did not provide details about the expected content of the discussions, though the company noted that the part of the hearing that’s open to the public will be held virtually.

Lilly is running a separate Phase 3 trial, TRAILBLAZER-ALZ 3 (NCT05026866), to test whether donanemab might be able to prevent Alzheimer’s from developing. The study aims to enroll about 2,600 people who have preclinical Alzheimer’s — that is, individuals who score normally on cognitive tests, but show evidence of abnormal clumps of the Alzheimer’s-related proteins amyloid-beta and tau in the brain.

Participants in TRAILBLAZER-ALZ 3 will be randomly assigned to receive intravenous infusions of donanemab or a placebo for about four years, and the study’s main goal is to assess how many patients experience a notable worsening of cognition in that time. The trial is ongoing at more than 200 sites in the U.S., including Puerto Rico, and Japan. Most sites are actively enrolling patients.