Today, 14 April 2025, the European Commission’s appeals board announced that they were unable to reach a verdict on the use of lecanemab in the treatment of early Alzheimer’s disease across the EU27 and EEA Member States.
Despite the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) reaffirming their positive opinion; the European Commission’s Standing Committee on Medicinal Products for Human Use were unable to reach an agreement which led to its consideration by the European Commission’s Appeal Board. The matter will now be referred the European Commission for a final decision.
On their website, the European Commission said:
The meeting was convened following the “no opinion” outcome of the vote that took place during the meeting of the Standing Committee on 21 March 2025.
The Committee was reminded that both draft Decisions concern the same medicinal product and are based on the same opinion of the Committee for Medicinal Products for Human Use (CHMP) dated 14 November 2024, recommending the marketing authorisation of Leqembi.
The voting on each of the two draft decisions took place separately. The outcome of both votes was ‘no opinion’, i.e. no qualified majority in favour of the two draft decisions.
The Commission answered some questions on the next steps, referring to Regulation (EU) No 182/2011 and the Rules of Procedure of the Appeal Committee.
On the news, ADI CEO, Paola Barbarino said:
We are deeply concerned about the impact that ongoing delays are having on people living with Alzheimer’s disease across Europe. For over two years, individuals and their families have waited for access to a treatment that could offer improvements in quality of life at the early stages of Alzheimer’s disease. For many, the progression of their disease during this time may now mean they are no longer eligible to benefit from these therapies.
While ADI does not take a position on the efficacy or safety of individual therapies, we strongly uphold the right of people living with Alzheimer’s to be fully informed and to choose whether such treatments should be part of their care.
Lecanemab has already been approved for use in the U.S. Japan, China, South Korea, Hong Kong, Israel, the United Arab Emirates, the United Kingdom, Mexico, Macau, Oman and Taiwan, and is under regulatory review in 15 countries and regions including the EU. Today’s news emphasises the disparity between the EU and other countries and regions, risking growing health inequalities caused by the lack of access to treatment across Europe, and further increasing the risk of people travelling for treatment or so called, health tourism.
ADI will continue to provide updates as and when they become available.
