John Hardy
Professor of Neuroscience and Group Leader at the UK Dementia Research Institute, UCL.
I have to say I am disappointed in the decision to not grant a license to Lecanemab for the treatment of Alzheimer’s disease. The EMA (in contrast to the FDA) has taken the view that the risk of ARIA outweighs the clinical benefit. The imaging abnormality seen in treated patients is usually either without symptoms or with only minor, headaches as symptoms, but is occasionally associated with brain haemorrhages. The question of whether the undoubted statistical benefit of treatment is worth the risk of serious, though rare side effects is always difficult with any treatment and on this occasion the EMA in Europe and the FDA in the US have reached different conclusions when presented with similar data. I am sure we will now see rich people with early Alzheimer’s disease flying to the US or other jurisdictions for treatment. My guess would be that this decision will be revisited as US clinicians and others gather and report real world experience with both lecanemab and the (very similar) dononemab treatments.