Eisai and Biogen have secured marketing authorisation from the European Commission for their Alzheimer’s treatment, Leqembi (lecanemab), in the European Union (EU).
Leqembi is an amyloid-beta monoclonal antibody that targets aggregated soluble amyloid-beta protofibrils and insoluble forms of amyloid-beta (Aβ).
It is indicated for the treatment of adult patients with mild cognitive impairment (MCI) and mild dementia due to AD (early AD), who are non-carriers of apolipoprotein E ε4 (ApoE ε4).
The EC authorisation marks the first approval in the EU for a therapy targeting an underlying cause of Alzheimer’s disease (AD).
It covers all 27 EU Member States, along with Iceland, Liechtenstein, and Norway.
Eisai CEO Haruo Naito said: “Today’s decision makes lecanemab the first treatment option in the EU that can slow the progression of early Alzheimer’s disease.
“We are proud that our about 40-year heritage in dementia has led to this important milestone, as we aim to be part of the solution for a better future for those impacted by this disease globally.
“Eisai is working collaboratively with national reimbursement authorities and healthcare providers to support access for those eligible for lecanemab as soon as possible.”
The EC approval was based on data from Eisai’s Phase 3 Clarity AD clinical trial, a placebo-controlled, double-blind, parallel-group, randomised study in 1,795 patients with early AD.
In the study, participants received Leqembi 10 mg/kg bi-weekly, with allocation in a 1:1 ratio to either placebo or Leqembi for 18 months.
The primary endpoint was the global cognitive and functional scale, CDR-SB, and the secondary endpoints include the AD Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment.
In the indicated population, common adverse reactions included infusion-related reactions, ARIA-H, headache, and ARIA-E.
Lecanemab has already been approved in China, Israel, Japan, Mexico, South Korea, the UK, and the US, and is under regulatory review in 14 other countries and regions.
Eisai leads the development and regulatory submissions globally, while both Eisai and Biogen co-commercialise and co-promote the product.
In the EU, Eisai and Biogen will co-promote Leqembi, with Eisai as the marketing authorisation holder, excluding the Nordic countries.
In the Nordic countries, Eisai will co-promote the medicine together with BioArctic.
Biogen president and CEO Christopher Viehbacher said: “The approval of lecanemab by the European Commission marks the thirteenth 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 which showed that the reduction of the 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.”
