Leqembi approved in EU as treatment for early Alzheimer’s
Therapy indicated for certain adults with mild cognitive issues or dementia
Leqembi (lecanemab) has won marketing authorization in the European Union for the treatment of certain adults with early Alzheimer’s disease, making it the first therapy that targets an underlying cause of the neurodegenerative condition to be approved in the region.
The treatment is indicated for adults with mild cognitive impairment or mild dementia due to Alzheimer’s who have confirmed buildup in the brain of the amyloid-beta protein — the disease hallmark that Leqembi targets. It should be used in people with one or no copies of the APOE4 gene variant, which is the strongest genetic risk factor for Alzheimer’s.
Leqembi was codeveloped by Biogen and Eisai. In most countries, the two companies are copromoting the medication, with Eisai responsible for its distribution. In Nordic countries, Eisai will copromote the medication with BioArctic, the company that originally developed Leqembi.
“[This] decision makes [Leqembi] the first treatment option in the EU that can slow the progression of early Alzheimer’s disease,” Haruo Naito, CEO of Eisai, said in a company press release.
Naito said the company is seeking to quickly get Leqembi to patients in the European Union.
“Eisai is working collaboratively with national reimbursement authorities and healthcare providers to support access for those eligible for [Leqembi] as soon as possible, aiming to make an impact not only on patients but also on their caregiving families and society in the EU,” Naito said.
Treatment for early Alzheimer’s aims to slow disease progression
The approval decision, by the European Commission, applies to all 27 EU member states as well as Iceland, Liechtenstein, and Norway.
Leqembi is also approved in other countries, including the U.S., Japan, China, and the U.K., and is under review elsewhere.
The treatment is given via intravenous, or into-the-vein, infusions at a standard dose of 10 mg/kg of body weight, once every two weeks. U.S. regulators earlier this year approved a maintenance dosing regimen, given once monthly, that can be considered for patients after 1.5 years of treatment.
A weekly subcutaneous, or under-the-skin, formulation of Leqembi — with the possibility for self-administration — is also under review in the U.S., with a decision expected by the end of August.
“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 United States, Japan and other regions of the world,” said Christopher A. Viehbacher, Biogen’s president and CEO.
A hallmark of Alzheimer’s is the toxic brain accumulation of amyloid-beta, which is believed to contribute to neurodegeneration and related symptoms.
Leqembi is an antibody designed to bind to and promote the immune system’s clearance of amyloid-beta as a way of slowing disease progression. It preferentially targets amyloid protofibrils — soluble amyloid clumps that are particularly neurotoxic and which are believed to play a major role in Alzheimer’s-related cognitive declines — but also targets insoluble clumps of the protein known as amyloid plaques.
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 United States, Japan and other regions of the world.
Leqembi’s EU clearance was backed largely by data from the global Phase 3 Clarity AD study (NCT03887455), which showed that its use slowed cognitive declines for people with early Alzheimer’s — including a subgroup whose members matched the EU-indicated population.
George Vradenburg, chair and cofounder of UsagainstAlzheimer’s, said the approval for patients in Alzheimer’s early stages “is a victory for patients and those who love them.”
“This treatment offers hope to patients and families facing this devastating — and ultimately fatal — disease,” Vradenburg said in a separate press release issued by the charity.
As with other amyloid-targeted antibodies, Leqembi comes with a risk of amyloid-related imaging abnormalities, or ARIA, which are a class of potentially serious or life-threatening side effects that can include brain swelling or bleeding. ARIA is more likely in people with two copies of the APOE4 genetic variant, which is why Leqembi is not indicated for those patients in the EU.
“We fully support precautions to protect patients while still making it possible for them to benefit from a treatment that has been shown to slow the disease in many people,” Vradenburg said, adding that the approval is “proof that momentum is building around the world to end Alzheimer’s.”
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