FDA Panel Endorses Eli Lilly’s Experimental Alzheimer’s Drug Donanemab

the staff of the Ridgewood blog

Ridgewood NJ, in a significant development, outside advisers to the U.S. Food and Drug Administration (FDA) unanimously endorsed the efficacy of Eli Lilly’s experimental Alzheimer’s drug, donanemab, for patients with early Alzheimer’s disease. This vote precedes the FDA’s impending decision on the drug’s approval. The panel’s discussion highlighted some unique aspects of Lilly’s trial, which differed notably from the trial design of Eisai and Biogen’s Leqembi, another Alzheimer’s drug that recently gained U.S. approval following a similar advisory committee review.

Both donanemab and Leqembi are designed to remove toxic beta-amyloid plaques from the brains of individuals with early Alzheimer’s disease. These antibody treatments have shown success in slowing disease progression in clinical trials, a breakthrough after three decades of failed attempts to develop effective Alzheimer’s drugs.

Several panelists noted post-vote that the underlying data, which examined amyloid levels, suggest donanemab could benefit people with early Alzheimer’s, including those with no or low levels of tau in their brains—individuals who were not included in the study population.

Although the FDA had initially planned to rule on donanemab earlier this year, it scheduled this meeting to allow its independent panel of experts to weigh in. While the FDA is not obligated to follow the recommendations of its outside advisers, it typically does so. The unanimous vote marks a promising step forward for donanemab and the potential treatment of early Alzheimer’s disease.

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