Eisai Receives Positive Opinion from the CHMP in the European Union for Lecanemab in Early Alzheimer’s Disease

The Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for lecanemab as a treatment for adult patients with a clinical diagnosis of mild cognitive impairment and mild dementia due to Alzheimer’s disease (AD) (early AD) who are apolipoprotein E ε4 (ApoE ε4*) non-carriers or heterozygotes with confirmed amyloid pathology¹

Lecanemab becomes the first therapy that targets an underlying cause of AD to be recommended for Marketing Authorisation in the European Union^1,2

The positive opinion is primarily based on data from the global Phase 3 clinical trial, Clarity AD, which demonstrated that lecanemab slowed disease progression vs placebo at 18 months^1,2,3Today’s opinion by the CHMP means that a Marketing Authorisation Application decision by the European Commission is expected within 67 days⁴

HATFIELD, HERTFORDSHIRE, UNITED KINGDOM, and CAMBRIDGE, Mass., 14 November, 2024 – Eisai Europe Ltd. and Biogen Inc. announced today that a positive opinion has been received from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending authorisation of the amyloid-beta (Aβ) monoclonal antibody lecanemab as a treatment for adult patients with a clinical diagnosis of mild cognitive impairment and mild dementia due to Alzheimer’s disease (AD) (early AD) who are apolipoprotein E ε4 (ApoE ε4)* non-carriers or heterozygotes with confirmed amyloid pathology.¹ The positive CHMP opinion makes lecanemab the first Aβ monoclonal antibody therapy that targets an underlying cause of AD to be recommended for Marketing Authorisation (MA) in the European Union (EU).^1,2 Eisai had requested a re-examination of the prior negative opinion adopted by the CHMP in July 2024. In accordance with the EMA regulatory process, the European Commission is expected to make a final decision on the Marketing Authorisation Application of lecanemab based on the CHMP recommendation within 67 days of receipt of CHMP opinion.⁴

Lecanemab is an Aβ monoclonal antibody that selectively binds to soluble Aβ aggregates (protofibrils**), as well as insoluble Aβ fibril aggregates, which are a major component of Aβ plaques in early AD, thereby reducing both Aβ protofibrils and Aβ plaques in the brain.^2,5,6,7

The CHMP’s opinion was primarily based on Phase 3 data from Eisai’s global, placebo-controlled, double-blind, parallel-group, randomised Clarity AD clinical trial, in which the medicine met its primary endpoint (change from baseline in the Clinical Dementia Rating Sum of Boxes [CDR-SB]^† at 18 months) and all key secondary endpoints.² In the recommended indicated population, the most common adverse events in the treatment group (n=757) were infusion-related reaction, amyloid-related imaging abnormalities with haemorrhage (small spots of bleeding) (ARIA-H)^‡, headache and amyloid-related imaging abnormalities with cerebral oedema (build-up of fluid) (ARIA-E)^‡‡.^8,24

“Today’s positive CHMP opinion brings us one step closer to being able to offer a potential treatment option which targets an underlying cause of AD to eligible patients in the EU for the first time,” said Gary Hendler, Regional Chairman and CEO, Eisai EMEA, Senior Vice President & Global Corporate Officer, Eisai Co. Ltd, Tokyo. “AD is a progressive neurodegenerative disease that poses significant challenges to human health and wider society – the loss of someone’s memory and independence can have a significant impact on not only those living with the disease, but also their family and friends. Eisai is committed to making a meaningful difference to all those affected by AD, and we are pleased that our ongoing work with the CHMP is helping to make this available to eligible patients in the EU.”

AD currently affects 6.9 million people in Europe,⁹ and this figure is expected to nearly double by 2050 as ageing populations increase.¹⁰ AD progresses in stages that increase in severity over time,¹¹ and each stage of the disease presents different challenges for those living with AD and their care partners.¹² There is a significant unmet need for new treatment options that slow down the progression of early AD and reduce the overall burden on people affected by AD and society.¹³

“The positive CHMP opinion marks a significant step and recognises the potential of this medicine to make a difference to eligible individuals and their families impacted by this disease. We look forward to the EC’s decision and are pleased to be one step closer to offering this medicine in the EU,” said Wolfram Schmidt, President, Head of Europe, Biogen. “As a company, we are dedicated to furthering Alzheimer’s disease research and treatment, aiming to help address the unmet needs in this devastating condition.”

Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercialising and co-promoting the product and Eisai having final decision-making authority.

^*Apolipoprotein E is a protein involved in the metabolism of fats in humans. It is implicated in AD.

^**Protofibrils are believed to contribute to the brain injury that occurs with AD and are considered to be a key toxic form of Aβ, having a primary role in the cognitive decline of this progressive, debilitating condition.¹⁴ Protofibrils can cause injury to neurons in the brain which in turn, can negatively impact cognitive function via multiple mechanisms,¹⁴ not only increasing the development of insoluble Aβ plaques but also increasing direct damage to brain cell membranes and the connections that transmit signals between nerve cells or nerve cells and other cells.¹⁵ It is believed the reduction of protofibrils may slow the progression of AD by reducing damage to neurons in the brain and cognitive dysfunction.¹⁵  

^†CDR-SB is a disease staging tool used in clinical trials, which can help to stage dementia due to AD.¹⁶ It is a global cognitive and functional scale that measures six domains of functioning, including memory, orientation, judgement and problem solving, community affairs, home and hobbies and personal care.¹⁶

^‡ARIA-H: amyloid-related imaging abnormalities with haemorrhage (cerebral microhaemorrhages and superficial siderosis).

^‡‡ARIA-E: amyloid-related imaging abnormalities with oedema (oedema/effusion).

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