Honestly, the world of Alzheimer’s research moves so fast that it’s easy to miss the nuance between a "recommendation" and an actual green light. But we finally hit the big one. In late September 2025, with the official paperwork rolling into October, the European Commission approves donanemab (marketed as Kisunla), making it the second disease-modifying therapy to land in the EU.
It wasn't a smooth ride. Not even close.
If you’ve been following this, you know the European Medicines Agency (EMA) originally said "no" back in March 2025. They were worried—rightfully so—about brain swelling and bleeding. But after a high-stakes re-examination and a major rethink on which patients actually benefit, the gates have finally opened. This isn't just another pill for memory; it’s a monthly infusion that actually scrubs the brain of amyloid plaques.
The Reversal: Why the EU Changed Its Mind
You don't usually see the EMA pull a U-turn this quickly. What changed?
Basically, it came down to being picky. The European Commission didn't just give Eli Lilly a blank check to treat everyone. Instead, they focused on a "restricted population." Specifically, the approval is for adults with mild cognitive impairment or mild dementia who have one or no copies of the ApoE4 gene.
Why does that tiny genetic detail matter? Because people with two copies of that gene—the "homozygotes"—are at a much higher risk for a side effect called ARIA (Amyloid-Related Imaging Abnormalities). ARIA is basically a fancy medical term for brain swelling or tiny bleeds. By cutting out the high-risk group, the regulators decided the benefits finally outweighed the risks.
The numbers from the Phase 3 TRAILBLAZER-ALZ 2 study are what really pushed it over the line. We're talking about a 35% slowing of cognitive decline over 18 months. For a family watching a loved one disappear bit by bit, that 35% represents more than just a statistic. It’s more time to recognize faces, more time to hold a conversation, and more time to live independently.
European Commission Approves Donanemab: How It Works Differently
Most people think of Alzheimer's drugs as something you take forever, like blood pressure medication. Donanemab is different. It’s sorta like a "search and destroy" mission for the brain.
- Once-Monthly Infusion: You go into a clinic, get the drip, and go home.
- The "Stopping" Feature: This is the big one. Donanemab is the first therapy where you can actually stop treatment once your brain is clean of plaques.
- Amyloid Clearance: In the trials, about half of the patients were able to stop the drug within a year because their PET scans showed the amyloid was basically gone.
This "limited course" model is a huge deal for the European healthcare systems. It means they aren't paying for an expensive infusion indefinitely. Once the job is done, the patient moves to monitoring. It reduces the "infusion burden" and, frankly, keeps costs from spiraling into the stratosphere.
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Comparing the Players: Donanemab vs. Lecanemab
Europe already approved Lecanemab (Leqembi) earlier in 2025. So, which one is better?
There’s no simple answer, but the data suggests donanemab is a more aggressive "scrubber." In head-to-head comparisons of plaque clearance, donanemab showed a clearance rate of nearly 38% compared to a much lower percentage for its competitor in certain stages. However, that power comes with a price—it tends to cause ARIA more frequently, which is why the EU is being so strict about MRI monitoring.
The Reality Check: What Happens Now?
Just because the European Commission gave the thumbs up doesn't mean you can walk into a pharmacy in Madrid or Berlin today and get it.
Now we enter the "national phase." Each country in the EU—Germany, France, Spain, Italy, etc.—has to decide if they’re going to pay for it. They’ll look at the price Eli Lilly sets and weigh it against their national budgets. This is where things usually get sticky.
Doctors will also need to be trained. You can't just give this stuff out. You need a clinical team that knows how to read an MRI for signs of ARIA. The EU's approval comes with a "controlled access program," meaning only certain specialized centers will likely be able to administer it at first.
Who can actually get it?
To qualify for Kisunla in Europe, you've gotta check some specific boxes:
- Early Stage: You must be in the mild cognitive impairment or mild dementia stage.
- Confirmed Amyloid: You need a PET scan or a lumbar puncture to prove the plaques are actually there.
- Genetic Testing: You must be an ApoE4 heterozygote (one copy) or a non-carrier. If you have two copies, you're out.
- MRI Clearance: No history of major brain bleeds or certain vascular issues.
Looking Ahead to 2026 and Beyond
The approval of donanemab in late 2025 is a massive milestone, but it’s just the beginning. There's another study called TRAILBLAZER-ALZ 3 currently running. That one is looking at people who have amyloid in their brains but no symptoms yet. If that study succeeds in 2027, we might move from treating Alzheimer's to actually preventing it before the first "Where are my keys?" moment even happens.
For now, the focus is on safety and logistics. It’s a messy, complicated rollout, but for the roughly 7 million Europeans living with this disease, it’s a legitimate reason to feel hopeful.
Next Steps for Patients and Families:
If you or a loved one are in the early stages of cognitive decline, the first step is a formal diagnosis from a neurologist who specializes in dementia. You’ll want to ask specifically about ApoE4 genetic testing, as this is now the gatekeeper for access to donanemab in the EU. Once your genetic status is known, you can work with your medical team to see if your local health system has begun the "Early Access" or reimbursement protocols for Kisunla. Keep in mind that private insurance may cover it sooner than public health systems in certain regions.