The Food and Drug Administration (FDA) has announced a delay in its decision regarding the approval of the Alzheimer’s drug, donanemab, which was anticipated to receive approval this month. Eli Lilly and Company, the manufacturer of the drug, disclosed on Friday that the FDA will require donanemab to undergo evaluation by a panel of independent experts.
The unexpected decision by the FDA comes as a surprise to many Alzheimer’s experts, healthcare professionals, and patients who were anticipating the drug’s imminent approval. Anne White, an executive vice president of Lilly and president of its neuroscience division, expressed her surprise in an interview, stating, “We were not expecting this.”
While it is common for the FDA to seek input from independent advisory committees regarding drug evaluations, it is unusual for such action to occur at the conclusion of the review process, beyond the anticipated action date provided by the FDA.
The FDA’s decision to convene an advisory committee underscores the significant challenges and uncertainties associated with the development of treatments for Alzheimer’s disease. Alzheimer’s affects over six million Americans and currently lacks a cure or medication capable of reversing cognitive decline.
Donanemab, administered through monthly infusions, belongs to a new class of drugs aimed at targeting the protein amyloid, which forms plaques in the brains of Alzheimer’s patients. Last year, the FDA approved another drug in this class, Leqembi, manufactured by Eisai and Biogen, which can modestly slow cognitive decline in the early stages of Alzheimer’s.
However, these new drugs are viewed as only a preliminary step in Alzheimer’s treatment, as they may not sufficiently slow decline to be perceptible to patients or families and carry significant safety risks, including brain swelling and bleeding.
Donanemab was expected to receive approval due to its ability to modestly slow cognitive decline in individuals with mild symptoms, with safety risks comparable to those of Leqembi. However, differences in trial design between donanemab and Leqembi necessitate separate evaluations.
The donanemab trial featured unique aspects, including a provision to discontinue treatment once amyloid plaques reached a certain level, resulting in continued slowing of cognitive decline. Additionally, the trial categorized participants based on tau protein levels, with individuals demonstrating intermediate tau levels experiencing greater cognitive improvement, supporting the theory that early intervention may be more effective in Alzheimer’s treatment.
The FDA’s request for further review suggests a desire to comprehensively evaluate these novel trial features and their implications for treatment. While this delay is disappointing for those eagerly awaiting the drug’s approval, Lilly remains confident in its data and plans to address any questions raised during the review process.
In the meantime, the Alzheimer’s community continues to grapple with the urgent need for effective treatments amidst the ongoing challenges posed by the disease. The delay underscores the complexity of Alzheimer’s research and the FDA’s commitment to ensuring the safety and efficacy of new treatments before they reach the market.
 has announced a delay in its decision regarding the approval of the Alzheimer's drug, donanemab, which was anticipated to receive approval this month. Eli Lilly and Company, the manufacturer of the drug, disclosed on Friday that the FDA will require donanemab to undergo evaluation by a panel of independent experts.){kind=link}