Adcomm Unanimously Approves Lilly’s Alzheimer’s Drug Donanemab

In a significant development for Alzheimer’s treatment, the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee unanimously endorsed Eli Lilly’s drug, donanemab. The committee, consisting of eleven members, voted in favor of the medication, recognizing its effectiveness for patients with mild cognitive impairment and mild dementia due to Alzheimer’s, and concluding that its benefits surpass associated risks.

Dr. Kathleen Poston, director of neurological science at Stanford’s Movement Disorders Center, supported the approval based on robust clinical data and biomarker evidence that demonstrated the drug's impactful results across various patient subgroups.

The backdrop to donanemab's approval includes comparisons to past treatments like Biogen’s Leqembi, which was the first to address amyloid beta plaques, a suspected cause of Alzheimer’s. Another similar drug, Aduhelm, was introduced with accelerated approval but faced critical debate over its efficacy, leading to its eventual discontinuation. In contrast, Leqembi has seen a rise in commercial success, generating $19 million in sales in the first quarter of 2024, compared to $7 million in the last quarter of 2023.

Donanemab aims to compete directly with Leqembi in the market. Analysts at Jefferies suggest that the presence of both drugs could benefit both Eli Lilly and Biogen. Their report articulates that having multiple players could lead to enhanced investment in healthcare infrastructure, increased resource allocation, and more extensive patient and physician education, fostering overall market growth and treatment accessibility.

Despite the positive vote, the FDA highlighted several concerns regarding donanemab’s efficacy and safety. A notable point of contention is Eli Lilly’s integrated Alzheimer’s Disease Rating Scale (iADRS), which combines scores from two accepted measures for assessing Alzheimer’s disease. The FDA critiqued this scale, noting that the original trial design had a different endpoint, and expressed disapproval of iADRS as a measure in 2021.

Additionally, the FDA questioned the selection criteria based on tau protein levels in the study population. Specifically, the exclusion of patients with no to very low levels of tau raised concerns, prompting the advisory committee to evaluate the effectiveness of donanemab across these subgroups. Although the tau protein debate was extensive, it did not significantly influence the committee’s final decision. Dr. Cynthia Carlsson, a senior professor at the Wisconsin Alzheimer’s Disease Research Center, emphasized that the tau analysis had no substantial impact on the drug's scientific validity and argued that using tau levels to determine eligibility could restrict patient access.

The committee also noted a lack of sufficient data on underrepresented groups, including African Americans, Hispanics, individuals with Down syndrome, and those with autosomal-dominant Alzheimer’s disease. The committee members stressed the need for further research to fully understand donanemab’s impact on these populations.

Overall, the advisory committee’s recommendation marks a crucial step forward for Eli Lilly’s donanemab, potentially offering a new effective treatment option for those suffering from the early stages of Alzheimer’s disease.

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