Lecanemab: Experts criticise European Commission approval of Alzheimer’s drug

Expert advisers including neurologists and patient representatives have expressed concern at the European Commission’s (EC) decision to formally approve the Alzheimer’s drug lecanemab (Leqembi) despite uncertain benefits.

Lecanemab, manufactured by Eisai, is the first disease modifying drug to treat Alzheimer’s disease to be approved in Europe. It is a monoclonal antibody that binds to aggregate forms of amyloid β and, by doing so, reduces β plaques.

In July 2024 the European Medicines Agency (EMA) rejected a marketing authorisation request for the drug on the grounds that its small effect in delaying cognitive decline “does not counterbalance the risk of serious adverse events.”12 The EMA reversed this decision after an appeal by the manufacturer and last month upheld its decision to recommend the drug.3

On 15 April the EC formally granted authorisation for lecanemab to treat mild cognitive impairment in the early stages of Alzheimer’s disease, under “strict conditions.”4

The EMA said in November 2024 …