Following recent developments regarding the marketing authorisation approval of lecanemab, Alzheimer Europe has written to Olivèr Vàrhelyi, the European Commissioner for Health and Animal Welfare, to express grave concern about the ongoing delays in the approval process.
On 1 April, Eisai and Biogen announced that the European Commission has decided to refer the marketing authorisation approval decision of lecanemab in the EU to the Appeal Committee. Lecanemab, which is the first disease-modifying therapy for Alzheimer’s disease to be approved in Europe, received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in November 2024. This decision was subsequently reaffirmed during the CHMP meeting of February 2025.
At its March meeting, the European Commission’s Standing Committee on Medicinal Products for Human Use (SCMP) discussed the approval of lecanemab, following reaffirmation of the EMA's positive opinion. The Standing Committee was not able to reach consensus based on a qualified majority, voting a ‘no opinion’ outcome. In view of that vote, the European Commission will convene an Appeal Committee meeting. The Appeal Committee comprises representatives from each EU Member State and will make a final decision on the marketing authorisation for lecanemab.
Escalation of an approval decision to the Appeal Committee is unprecedented, occurring fewer than 10 times in over 3,500 procedures since 2013. In our letter to Commissioner Vàrhelyi, we express our grave concerns about the ongoing delays in the review process for lecanemab, emphasising Alzheimer Europe’s support for the independent assessment of medicines and the rigorous scientific evaluation conducted by the CHMP. We endorse the considered approach of the CHMP to manage risks associated with lecanemab, by narrowing the indication and imposing additional measures that enable access for individuals most likely to benefit from treatment, whilst excluding those at greatest risk of severe side effects. At a time when the European Commission highlights the importance of competitiveness and innovation, Alzheimer Europe believes that it would be the wrong signal to close Europe to innovative treatments that have been assessed as having a positive risk/benefit ratio by Europe's own regulatory agency.
Alzheimer Europe hopes that the Appeal Committee will affirm the positive opinion of the CHMP by a qualified majority, enabling Europeans to access this first disease modifying treatment for early Alzheimer’s disease.
