FDA Approves Donanemab for Early Alzheimer Disease Treatment
The US Food and Drug Administration has issued a highly-anticipated decision: the approval of donanemab—to be marketed as Kisunla by manufacturer Eli Lilly—for the treatment of early Alzheimer disease.
Donanemab joins a small but growing field of anti-amyloid drugs, including its direct competitor lecanemab. This novel class of drugs aims to slow Alzheimer disease progression by attacking amyloid plaques, which begin to accumulate far before symptoms emerge. Both are administered as intravenous infusions: donanemab once monthly and lecanemab biweekly.
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A significant difference between the 2 drugs is that donanemab dosing can be stopped after it clears amyloid from the brain. According to findings from the Phase III TRAILBLAZER-ALZ 2 study, upon which the approval is based, 17% of patients receiving donanemab in the 18-month-long clinical trial were able to discontinue the drug at 6 months, 47% stopped within a year, and 69% stopped within 18 months.
It is not yet known how long before amyloid levels begin to rise again after concluding donanemab treatment.
For some patients and providers, the safety risks may outweigh the benefits of slowing cognitive decline. In the same clinical trial, approximately one-fourth of those receiving donanemab experienced brain swelling and/or bleeding. Most instances were mild or asymptomatic, but 3 patient deaths were linked to the side effects from the drug.
>>RELATED: Lecanemab AD Treatment Could Have Low Eligibility Rate
While much attention has been paid to the potential anti-amyloid agents, there are many other clinical trials for Alzheimer disease in progress at this time exploring tau tangles and neuroinflammation as targets for treatment.
As B. Joy Snider, MD, professor of neurology at Washington University School of Medicine, said to The New York Times regarding the approval: “Hopefully, this is just the beginning.”
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