Eisai Co., Ltd. and Biogen Inc. announced that the European Commission (EC) has granted marketing authorization (MA) for Leqembi® (lecanemab), a monoclonal antibody targeting amyloid-beta (Aβ), for the treatment of early Alzheimer’s disease (AD). This decision marks the first time an Alzheimer’s therapy that modifies an underlying pathology of the disease has been approved for use in the European Union.

Leqembi is indicated for adults with a clinical diagnosis of mild cognitive impairment (MCI) or mild dementia due to Alzheimer’s disease (also referred to as early AD), who are ApoE ε4 non-carriers or heterozygotes and have confirmed amyloid pathology. The approval applies to all 27 EU member states, as well as Iceland, Liechtenstein, and Norway.

Leqembi is the only approved treatment in its class that selectively binds and clears toxic protofibrils—soluble aggregates of Aβ—while also targeting and reducing insoluble Aβ plaques. Protofibrils are considered one of the most damaging forms of Aβ, contributing to neuronal injury and the progression of cognitive decline in Alzheimer’s disease.

Alzheimer’s impacts a growing number of people in Europe, with an estimated 15.2 million individuals living with MCI due to AD, and 6.9 million with AD dementia. As the disease advances, patients and their caregivers face increasing challenges. There is a pressing need for therapies that slow disease progression in its early stages and ease the societal burden of Alzheimer’s.

“Today’s approval makes Leqembi the first treatment in the EU proven to slow the progression of early Alzheimer’s disease,” said Haruo Naito, CEO of Eisai. “This achievement is the result of nearly four decades of dedicated research in dementia. We are committed to working closely with national reimbursement authorities and healthcare providers to ensure swift access for eligible patients across Europe.”

“This marks the 13th regulatory approval for Leqembi globally and reflects its growing impact on Alzheimer’s care,” added Christopher A. Viehbacher, CEO of Biogen. “Leqembi is the first therapy to show that reducing amyloid plaques in the brain is linked with slowing cognitive decline in early Alzheimer’s. This is a pivotal step forward in a field that has seen little innovation for over 20 years.”