Alzheimer's drug donanemab gets FDA advisory committee's green light : Shots - Health News
How does donanemab target the pathology of Alzheimer's disease, according to the information provided?
Donanemab targets the pathology of Alzheimer's disease by specifically binding to N-terminally truncated pyroglutamate-modified amyloid β (AβpE), a type of amyloid plaque found in the brain of Alzheimer's patients4. By targeting these plaques, donanemab aims to clear them from the brain, which in turn slows down the progression of the disease. This is supported by the results of a phase 2 clinical trial, which showed a substantial reduction in Alzheimer's disease-associated cerebral amyloid-plaque load in patients who received donanemab compared to those who received a placebo46.
What specific benefits did the FDA advisory committee identify in donanemab compared to its predecessor, Leqembi?
The FDA advisory committee identified several specific benefits of donanemab compared to its predecessor, Leqembi. Firstly, donanemab is administered monthly, whereas Leqembi is given every two weeks indefinitely. This could mean fewer infusions for patients taking donanemab. Secondly, studies suggest that most patients could discontinue donanemab within a year if tests show that most amyloid plaques have been removed from the brain. This is not an option with Leqembi, which is given indefinitely. Lastly, the committee heard from doctors and patients who urged them to approve donanemab, citing its effectiveness in slowing down Alzheimer's in the disease's early stages.
What were the main concerns discussed by the committee regarding the risks associated with donanemab, particularly for patients with the APOE4 gene?
The main concerns discussed by the committee regarding the risks associated with donanemab, particularly for patients with the APOE4 gene, were the potential for swelling and bleeding in the brain. The APOE4 gene greatly increases the risk of Alzheimer's disease, but it also increases the risk of brain bleeding or swelling when receiving donanemab. The committee members were especially concerned about these risks for APOE4 carriers and emphasized the need for clear educational materials to inform doctors and patients about these potential side effects.