Donanemab (Kisunla) and European approval: a new era for Alzheimer's treatment

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) is accompanying Alzheimer's disease treatment drugs, hand by hand, in their first steps into Europe. The European Commission is expected to make a regulatory decision on donanemab (Kisunla) in the coming months. The CHMP describes the drug as intended for the treatment of early symptomatic Alzheimer's disease, targeting a reduced progression of cognitive and functional deficits. This is a genuinely historic moment: for the first time, Europe is on the verge of having approved disease-modifying therapies (DMTs) that can meaningfully slow the course of Alzheimer's.

What excites me most about this regulatory progress is not just what these drugs can do today — it is what they point to for tomorrow. Donanemab and therapies like it work by targeting amyloid-beta plaques in the brain, the pathological hallmark of Alzheimer's disease. Their effectiveness is highest when administered early, before irreversible neuronal damage has accumulated. This means the real bottleneck for these therapies is not manufacturing or even access to the drug itself: it is early and accurate diagnosis. To treat patients at the right moment, we first need to identify them at the right moment — and that requires high-quality amyloid PET imaging or equivalent confirmatory biomarker testing.

This is precisely where I find the situation both inspiring and urgent. At PraanaTech, we are working to ensure that the diagnostic infrastructure needed to unlock these therapies is accessible not just at elite academic medical centers, but across the full spectrum of healthcare settings. What if we do not need to wait for cognitive impairment to appear before we intervene? That is not a rhetorical question — it is a scientific and engineering challenge we are actively solving. The arrival of DMTs in Europe creates a new imperative: we must build the diagnostic capacity to match. For everyone, everywhere.