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 that its benefits don’t outweigh the risk of brain swelling or bleeding.
The treatment for early Alzheimer’s disease, which is administered via a monthly infusion, has already been approved in the United States, the United Kingdom, Japan and China. In March, the EMA’s human medicines committee CHMP rejected the drug saying there was a risk of “potentially fatal events due to amyloid-related imaging abnormalities (ARIA).”
But on Thursday, after re-examining the drug at the request of Lilly, the CHMP recommended granting Kisunla marketing authorization for patients who do not have a copy or only have one copy of the ApoE4 gene, a gene that puts them at a greater risk of Alzheimer’s disease.