Alzheimer Europe responds to the negative opinion on lecanemab by the European Medicines Agency

Background

On 26 July 2024, the Committee for Medicinal Products for Human use (CHMP) of the European Medicines Agency (EMA) issued a negative opinion on the marketing authorisation application of Eisai for lecanemab for the treatment of early Alzheimer’s disease. In its opinion, the CHMP identified the risk of amyloid-related imaging abnormalities (also known as ARIA) as a major issue. In particular, the CHMP was concerned by the elevated risk of ARIA in people with two copies of the Apo-Eε4 gene. The CHMP concluded that the benefits of lecanemab in slowing cognitive decline did not outweigh the risks of serious adverse events. 

Response

The negative opinion came as a disappointment to the AD community, which had high expectations about the introduction of new treatments in Europe. Alzheimer Europe regrets the negative opinion from the CHMP and hopes that the re-examination will result in a decision that will allow people with early AD in the European Union, Iceland, Liechtenstein and Norway to access treatment options available in other countries, with stringent eligibility criteria and efficient monitoring of side effects to ensure patient safety

Following on from the CHMP opinion, Alzheimer Europe has engaged in discussions with its member organisations, Working Groups and other members of the dementia community, developing an official response to the opinion outlining key concerns and a call to action. The response, which was shared with Emer Cooke, the Executive Director of EMA, and members of the CHMP on 11 October, identifies six key areas of concern for Alzheimer Europe:

  • Excluding European patients from treatments available in other countries risks exacerbating inequity. The CHMP opinion is at odds with the decisions by regulatory authorities in the United States, Japan, China, South Korea, Hong Kong, Israel, the United Arab Emirates and the United Kingdom, which means that wealthier patients may seek treatment abroad; creating disparities, and worsening health inequalities.
  • Excluding all patients from anti-amyloid treatments restricts patients’ autonomy and reduces choice. Patients and their families deserve the right to engage in discussions with their physicians, to make informed decisions about treatment based on their individual circumstances, preferences and values. 

Alzheimer Europe's full position can be downloaded below.