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 mild cognitive impairment or mild dementia due to Alzheimer's disease. In its opinion, the CHMP found that the benefits of treatment are not large enough to outweigh the risks associated with lecanemab, an anti-amyloid drug that has been approved by regulators in the US, Japan, China, South Korea, Hong Kong, and Israel.
The EMA decision affects people with Alzheimer's disease in the European Union, Iceland, Liechtenstein and Norway. Separate applications are pending with Swissmedic and the Medicines and Healthcare products Regulatory Agency, for patients in Switzerland and the United Kingdom. Read some of the reactions to the EMA decision from our member associations, by clicking the links below.
- The Czech Republic (Česká alzheimerovská společnost): https://www.alzheimer.cz/clanky/novinky-cals/alzheimer-europe-lituje-rozhodnuti-ema/
- Denmark (Alzheimerforeningen): https://www.alzheimer.dk/nyheder/2024/medicinen-lecanemab-risikerer-ikke-at-blive-godkendt-i-eu/
- France (France Alzheimer): https://www.francealzheimer.org/leqembi-commercialisation-refusee-en-europe/
- Germany (Deutsche Alzheimer Gesellschaft): https://www.deutsche-alzheimer.de/artikel/alzheimer-medikament-leqembi-nicht-zugelassen-deutsche-alzheimer-gesellschaft-zur-entscheidung-der-europaeischen-arzneimittel-agentur-ema
- Ireland (the Alzheimer Society of Ireland): https://alzheimer.ie/creating-change/awareness-raising/statements-from-the-alzheimer-society-of-ireland/
- The Netherlands (Alzheimer Nederland): https://www.alzheimer-nederland.nl/nieuws/alzheimermedicijn-lecanemab-niet-beschikbaar-in-europa
- Poland (Polskie Stowarzyszenie Pomocy Osobom z Chorobą Alzheimera): https://alzheimer-waw.pl/komunikat-dla-mediow-aux-medias-medienmitteilung/
- Spain (Confederación Española de Alzheimer): https://www.ceafa.es/es/que-comunicamos/notas-de-prensa-y-comunicados/ceafa-se-suma-a-la-postura-de-alzheimer-europe-y-lamenta-que-la-opinion-negativa-de-la-ema-sobre-el-lecanemab-prive-a-los-europeos-con-enfermedad-de-alzheimer-de-los-medicamentos-disponibles-en-estados-unidos-y-en-otros-paises
- Switzerland (Alzheimer Schweiz Suisse Svizzera): https://www.alzheimer-schweiz.ch/fr/medias/article/lema-soppose-a-la-mise-sur-le-marche-du-lecanemab
- Sweden (Demensforbundet): https://www.demensforbundet.se/ema-europeiska-lakemedelsmyndigheten-avslar-den-nya-bromsmedicinen-mot-alzheimer-lecanemab-leqembi-i-europa/
- The United Kingdom (England, Wales and Northern Ireland; the Alzheimer’s Society): https://www.alzheimers.org.uk/news/2024-07-26/alzheimers-society-responds-eus-rejection-lecanemab