Reacción a "EMA recommends not to approve lecanemab against Alzheimer's disease"

EMA's decision on lecanamab reflects the complex considerations that had to be taken into account. On the one hand, this is a novel therapeutic option that appears to affect the causes of a devastating condition for which we only currently have symptomatic treatment. An approval would have been a positive sign for further innovation in dementia drug development and create impetus for redesigning the dementia care pathways across the EU and elsewhere. On the other hand, the cognitive benefits for with syndromal stage of Alzheimer's disease are at best modest and occur in the context of significant side effects. In addition, the investment required to deploy this novel treatment for dementia is substantial: an economic analysis showed that the cost of the drug alone equals half of the current medication budget of the EU (assuming it was given to everyone who is eligible).

In my view, the decision creates pressure on EMA to create clear guidance on what clinically meaningful benefit in syndromal Alzheimer's disease is. This will help to maintain the momentum created by the amyloid clearance therapies break-through and offer hope for those living with or at-risk for dementia.