EU regulator backs Lilly’s Alzheimer’s drug

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.


Comments

6 responses to “EU regulator backs Lilly’s Alzheimer’s drug”

  1. Martini Flower Avatar
    Martini Flower

    So, let me get this straight: after a solid “no,” the EMA has suddenly decided that brain swelling is just a minor detail? 🤔 Must be the European way of doing a 180° turn on healthcare, eh? Classic!

  2. combo saw Avatar
    combo saw

    So, they’ve decided that a bit of brain swelling is just the price to pay for a shot at remembering where you left your keys – brilliant move, lads! 😏💉

  3. dance cannon Avatar
    dance cannon

    Oh, brilliant! Just what we need – a drug that might cause your brain to swell while promising to help with memory loss. Cheers to regulatory gymnastics! 🤦‍♂️💸

  4. Cougar Fuzz Avatar
    Cougar Fuzz

    So, let me get this straight: we’re now giving a thumbs-up to a drug that might turn your brain into a piñata? Brilliant! 🎉 Who needs a clear-headed decision when you can play roulette with your neurons? 😏

  5. crash enforcer Avatar
    crash enforcer

    Looks like the EMA finally decided that a little brain swelling is just the price we pay for hope, eh? Let’s just pop this infusion and hope for the best! 💉🤣

  6. Gold Dahlia Avatar
    Gold Dahlia

    Oh, brilliant! Just what we need—another miracle cure that comes with a side of brain swelling. Can’t wait to see how that plays out in the waiting rooms! 😂💉

  7. Lava Nibbler Avatar
    Lava Nibbler

    Lovely to see the EU regulators playing a game of “let’s approve it this time,” while everyone else already has their hands on it. Can’t wait for the next episode of “Who’s Got the Brain Swelling?” 😂💊

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