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The FDA has approved a safer dosing schedule for Eli Lilly’s Alzheimer’s drug, Kisunla, which could make it more appealing to doctors and patients. The updated schedule reduces the risk of a serious side effect called ARIA-E—brain swelling caused by anti-amyloid drugs.
Originally, Kisunla was given in higher doses early on. Now, the drug will be introduced more slowly. Patients will start with one vial, then increase to two, three, and finally four vials over several months, still taken every four weeks. This gradual increase lowered ARIA-E risk by up to 41% in a clinical study called Trailblazer-Alz6.
By week 24, only 14% of patients on the new regimen experienced ARIA-E compared to 24% on the original. After a year, the rates were 16% and 25%, respectively. Importantly, no one on the new regimen developed severe ARIA-E, while two people did on the original plan.
Despite the lower risk, the new schedule didn’t weaken the drug’s main effect: reducing amyloid plaques in the brain. Patients still saw about a 67% drop in these plaques, similar to the original dosing group.
However, the study didn’t find much difference in another side effect, ARIA-H, which involves brain bleeding. A larger trial would be needed to determine that risk more clearly.
Sales of Kisunla have been slow, with just $21.5 million in early 2025. Experts say safety concerns and complex diagnosis methods have made doctors hesitant. A new FDA-approved blood test for Alzheimer’s may help, but it could take time to make an impact.
Researchers are now watching a major trial, Trailblazer-Alz3, which is testing Kisunla in people who show brain changes but no symptoms. Results from this trial could change how Alzheimer’s is treated in the future.
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