European regulators on Friday said that Eli Lilly’s Alzheimer’s treatment Kisunla should be approved for a select group of patients, changing course from an initial recommendation to reject the drug.
A European Medicines Agency committee ruled in March that the risks of the therapy — namely a type of brain swelling and bleeding known as ARIA — outweighed the limited benefits of the treatment, calling for it to be denied.
But following an appeal from Lilly, the committee issued a limited recommendation Friday, saying Kisunla should be authorized for patients whose genetic profile leaves them at lower risk for ARIA.
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