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.
The EMA said the treatment should be administered as part of a controlled access program and under the supervision of physicians trained in detecting and managing ARIA. It also mandated additional measures to manage the risk, including more stringent rules for stopping treatment, and said patients must start with a lower dose.
Taking into account the new dosing regimen and the additional measures to reduce the risk of ARIA, the EMA said Kisunla’s benefits “outweigh its risks in noncarriers and people with just one copy of ApoE4.”
“This positive opinion marks a significant milestone in our efforts to bring donanemab to eligible patients across Europe,” said Patrik Jonsson, executive vice president and president of Lilly International. “Donanemab has the potential to make a meaningful difference for people living with early symptomatic Alzheimer’s disease.”
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