New FDA-Approved Dosing Schedule for Donanemab May Reduce ARIA-E Rates
Findings from the TRAILBLAZER-ALZ 6 study revealed a 41 percent reduction of the ARIA-E side effect at 24 weeks with the new dosing schedule for the anti-amyloid treatment donanemab-azbt.
The Food and Drug Administration (FDA) has approved dosing changes for the anti-amyloid therapy donanemab-azbt, which is utilized in the treatment of patients with early symptomatic Alzheimer’s disease.
Emphasizing a modified titrated dosing schedule, the new dosing for donanemab-azbt (Kisunla, Lilly) reportedly shifts a single vial from initial dosing to the third dose.
In the recent TRAILBLAZER-ALZ 6 study, researchers found that the modified dosing for donanemab-azbt facilitated a 41 percent reduction of amyloid-related imaging abnormalities with edema/effusion (ARIA-E) at 24 weeks and a 35 percent reduction at 52 weeks in comparison to the original dosing for the anti-amyloid therapy.
"This updated dosing strategy is a meaningful advancement for patients and their care teams," said Elly Lee, MD, chief medical officer and principal investigator at the Irvine Center for Clinical Research in Irvine, Calif. "By significantly reducing the risk of ARIA-E, we can offer patients and care teams greater confidence in the safety of Kisunla while preserving its ability to reduce amyloid."
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