Is Donanemab a Breakthrough Treatment for Alzheimer’s?

June 12, 2024

The FDA advisory group recently gave its approval to donanemab, a drug made by Eli Lilly to treat Alzheimer’s. This unanimous vote shows that the drug may help people in the early stages of Alzheimer’s disease more than it hurts them. The advisory’s approval is very important because it sets the stage for the FDA’s final decision on the drug’s approval.

What is Alzheimer’s Disease?

Alzheimer’s disease is a neurological problem that gets worse over time. It mostly affects the brain and causes memory loss and dementia. Memory loss, confusion, and changes in behavior and attitude are some of the most common signs. People aged 65 and up are most likely to get it, but early-onset Alzheimer’s can happen much younger.

What is Donanemab?

Donanemab is an experimental antibody treatment that targets N3pG amyloid, a changed form of beta-amyloid. Its goal is to slow down the loss of cognitive function and memory in people with Alzheimer’s disease. Donanemab was created by Eli Lilly and has been shown in Phase 2 clinical trials released in 2021 to have the potential to reduce amyloid plaques by a large amount within 6 months of treatment. In 2021, the FDA called it a “Breakthrough Therapy” because the early results looked so good. Donanemab works by focusing on specific amyloid plaques. This makes it different from other amyloid-targeting treatments because it targets plaques that are most likely causing cognitive impairment. It has been linked to some possible side effects, though, such as amyloid-related imaging abnormalities (ARIA), which can lead to brain swelling and small bleeding events.

Unique Trial Design and Comparative Analysis

Unlike other drugs, donanemab’s trial plan included choosing participants by checking the levels of tau, a second protein linked to Alzheimer’s. The goal of this method was to find patients who would likely gain during the 76-week trial period, leaving out those whose tau levels were low or not present at all. Compared to Eisai and Biogen’s Alzheimer’s drug Leqembi, which followed a different procedure, the results of their trials showed different safety and effectiveness results.

Safety Concerns and Efficacy

When given once a month through an IV, donanemab treatment slowed the onset of cognitive decline by 29%. However, it came with a lot of risks, such as brain swelling and bleeding, and in some cases, very bad things happened. The panelists talked at length about these safety problems, especially those that involved patients with genetic predispositions like the APOE4 gene. This shows that patients need to be carefully chosen and supervised.

Implications of Panel Recommendations

The FDA is not required to accept the advice of the advisory panel, but in the past, it has done so most of the time. The FDA’s final decision could be affected by the panel’s approval and new trial tactics, such as stopping treatment after plaque clearance. Concerns were made about how well this method could be used to manage treatment cycles, though.

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