Eisai and Biogen have received marketing authorisation (MA) from the European Commission (EC) for Leqembi (lecanemab) to treat Alzheimer’s disease.
This authorisation makes the amyloid-beta (Aβ) monoclonal antibody the first to address the underlying cause of Alzheimer’s in the European Union (EU).
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It extends to all 27 member states, along with Liechtenstein, Norway and Iceland.
The antibody is now approved for treating adults diagnosed with mild cognitive impairment and mild dementia due to Alzheimer’s, specifically for those who are non-carriers or heterozygotes of the apolipoprotein E ε4 (ApoE ε4) with confirmed amyloid pathology.
It preferentially attaches to and clears toxic protofibrils, which are soluble amyloid-beta aggregates associated with neuronal injury, in addition to targeting and decreasing amyloid-beta plaques.
Eisai is spearheading the development and regulatory rollout activities for the antibody worldwide, with both Biogen and Eisai responsible for the joint commercialisation of the product. Eisai holds final decision-making authority.
Within the EU, excluding the Nordic nations, the companies will jointly promote the antibody, with Eisai responsible for distribution as the holder of the MA.
In the Nordic nations, Eisai, along with BioArctic, will carry out promotion with Eisai distributing the product as the holder of the MA.
Biogen CEO and president Christopher Viehbacher stated: “The approval of lecanemab by the EC marks the 13th approval of this important medicine, which has already benefitted thousands of patients in the US, Japan and other regions of the world.
“Lecanemab is the first treatment that showed that the reduction of Aβ plaques in the brain is associated with the slowing of cognitive decline in patients at the early stage of the disease. This is a landmark advancement in a field where there has been no or little innovation in the past 20 years.”
