EU medicines agency reverses course on Eli Lilly's Alzheimer drug
In March, the EMA's drug safety committee said the risks of the drug outweighed its benefits, citing rare but potentially fatal side effects such as brain swelling and bleeding.
However, the agency now says the drug can be authorised for patients who either do not carry the ApoE4 gene or who carry only one copy of it, as this gene makes patients more susceptible to brain bleeding.
Treatments for the neurological disease remain costly and carry significant risks, offering only modest clinical benefit. But while Kisunla has already been approved in the US, UK, Japan, and China, Europe's slower response has raised concern among patient groups.
Alzheimer Europe welcomed the move, saying that they appreciated 'the careful approach that the EMA has taken to identify patients likely to benefit from treatment and to exclude those at greatest risk of harmful side-effects, such as people with two copies of the ApoE4 gene.'
"As with all anti-amyloid therapies, concerns around safety remain, and ongoing vigilance will be essential to ensure a favourable benefit-risk balance in real-world use,' Jean Georges, the Executive Director of Alzheimer Europe said in a press release.
This is not the first time the EMA has changed its position on Alzheimer's treatments. In 2024, it initially rejected Leqembi, developed by US firm Biogen and Japan's Eisai, before later approving it for a more narrow patient group.
The EMA's recommendation is pending a final decision from the European Commission.
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