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TGA beats FDA to updated label
Posted 17 July 2025 AM
A new dosing regimen with fewer side effects already used in Australia for Eli Lilly’s Alzheimer's disease drug Kisunla is now being rolled out in the US - and could have a positive impact on treatment uptake.
The updated FDA label, which is now in line with the label originally approved by the TGA in May 2025 involves a more gradual titration based on TRAILBLAZER-ALZ 6 study to lower the risk of amyloid-related imaging abnormalities with edema or effusion (ARIA-E).
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Posted 17 July 2025 AM
A new dosing regimen with fewer side effects already used in Australia for Eli Lilly’s Alzheimer's disease drug Kisunla is now being rolled out in the US - and could have a positive impact on treatment uptake.
The updated FDA label, which is now in line with the label originally approved by the TGA in May 2025 involves a more gradual titration based on TRAILBLAZER-ALZ 6 study to lower the risk of amyloid-related imaging abnormalities with edema or effusion (ARIA-E).
To see the whole article, please login
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