On 14 April, the minutes of the Appeal Committee of 7 April were published (https://ec.europa.eu/transparency/comitology-register/screen/documents/106785/1/consult?lang=en) which show that the Committee returned a “no opinion” outcome on the marketing authorisation application of lecanemab for the treatment of early Alzheimer’s disease. This means that the Committee made up of representatives of Member States was not able to reach a “qualified majority” of 55% of Member States representing at least 65% of the total EU population. As a result, the decision now reverts to the European Commission, which retains the authority to adopt or reject the draft implementing act granting the marketing authorisation for lecanemab in the EU, Iceland, Liechtenstein and Norway.
In advance of the Appeal Committee meeting, Alzheimer Europe had already addressed a letter to Commissioner Várhelyi on 3 April, expressing serious concerns about the approval process delaying the access of Europeans to the first disease-modifying treatment already available for people with early Alzheimer’s disease in China, Israel, Japan, Hong Kong, Macao, Mexico, Oman, South Korea, Taiwan, the United Arab Emirates, the United Kingdom and the US.
The letter reaffirmed Alzheimer Europe’s support for the comprehensive scientific assessment undertaken by the EMA’s Committee for Medicinal Products for Human Use (CHMP), which delivered a positive opinion on 11 November, subsequently re-confirmed on 24 February. The organisation commended the CHMP for its considered approach in managing potential risks by recommending additional safety measures and narrowing lecanemab’s indication by excluding populations at higher risk of severe side effects, such as people carrying two copies of the ApoE4 gene.
Alzheimer Europe now urges the European Commission to confirm the positive scientific assessment of the CHMP, by granting a marketing authorisation for lecanemab. Such a decision would allow individual patientsto make their own informed decisions with their treating doctors on risks and benefits, thereby preserving patient choice and autonomy, whilst allowing individual countries to make their decisions on the pricing, reimbursement and access to these medicines according to national priorities. At a time when the European Commission is championing innovation and competitiveness, Alzheimer Europe believes that denying access to a rigorously evaluated treatments with a positive risk-benefit profile would send the wrong signal about Europe’s openness to innovation in areas of high unmet medical need.