The European Medicines Agency has granted restricted EU authorization to Eli Lilly’s Alzheimer’s drug Kisunla, reversing an earlier decision to reject the drug over concerns about the risk of brain swelling or bleeding outweighing its benefits.
The treatment for early Alzheimer’s disease, administered via a monthly infusion, is already approved in the United States, the United Kingdom, Japan, and China. In March, the EMA’s human medicines committee CHMP rejected the drug, citing the risk of “potentially fatal events due to amyloid-related imaging abnormalities (ARIA).”
However, on Thursday, after a re-examination requested by Lilly, the CHMP recommended granting marketing authorization for Kisunla for patients who do not have a copy or only have one copy of the ApoE4 gene, which increases the risk of Alzheimer’s disease.
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