Leqembi® (lecanemab) Authorised for Early Alzheimer’s Disease in Great Britain

In Great Britain, lecanemab is indicated for the treatment of mild cognitive impairment and mild dementia due to Alzheimer’s disease (AD) in adult patients that are apolipoprotein E ε4 (ApoE ε4)* heterozygotes or non-carriers¹

Great Britain becomes the first country in Europe to authorise the medicine, which targets an underlying cause of AD¹

Authorisation based on data from the global Phase 3 trial, Clarity AD, which demonstrated that lecanemab slowed disease progression vs placebo at 18 months^1,2

Eisai is working collaboratively with health technology assessment bodies and the National Health Service to support access for eligible patients

HATFIELD, HERTFORDSHIRE, UNITED KINGDOM (UK), and MAIDENHEAD, UK, 22 August, 2024 – Eisai Europe Ltd. and Biogen International GmbH have announced today that Leqembi^® (lecanemab) has been granted a Marketing Authorisation (MA) by the Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain. Lecanemab is indicated for the treatment of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease (AD) in adult patients that are apolipoprotein E ε4 (ApoE ε4)* heterozygotes or non-carriers.¹ Great Britain is the eighth country in the world to grant MA, making lecanemab the first monoclonal antibody therapy for early AD (MCI and mild dementia due to AD)² that targets amyloid-beta (Aβ) to be authorised in a country in Europe.¹

The medicine was awarded an Innovative Licensing and Access Pathway (ILAP) passport by the MHRA in February 2023,³ as there is a significant unmet patient need for treatments that alter an underlying cause of the disease for people living with early AD.⁴ Lecanemab is a humanised Aβ monoclonal antibody that selectively binds to Aβ aggregate species with preferential activity for toxic Aβ protofibrils** (as well as fibrils, which are a major component of Aβ plaques).^1,2,5,6 It binds to these aggregate Aβ species to neutralise and clear them from the brain.^1,2,5,6

The approval 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 with statistically significant results.² In the indicated population in Great Britain, the most common adverse reactions were infusion-related reaction, amyloid-related imaging abnormalities with haemorrhage (small spots of bleeding) (ARIA-H)^‡, fall, headache and amyloid-related imaging abnormalities with cerebral oedema (build-up of fluid) (ARIA-E)^‡‡.^1,2

“Today signals a significant moment for the AD community. We are now one step closer to eligible people in Great Britain receiving a much-needed new treatment option that can slow disease progression, as demonstrated through clinical trials, by targeting an underlying cause of Alzheimer’s disease for the first time,” said Gary Hendler, Regional Chairman and CEO, Eisai EMEA, Senior Vice President & Global Corporate Officer, Eisai Co. Ltd, Tokyo. “This could mean maintaining independence and the ability to continue daily activities and hobbies for as long as possible. We are proud that 40 years of AD research has led to this important milestone.”

“The authorisation of lecanemab in Great Britain marks a significant step forward in the pursuit of innovation for AD,” said Wolfram Schmidt, President, Head of Europe, Biogen. “We remain steadfast in our mission to further AD research and bring treatment options to patients.”

In the UK, it is estimated that 982,000 people are living with dementia,⁷  and AD is the cause in 60-70% of people with dementia.⁸ These numbers are expected to rise, as the population ages.^7,8 People living with AD can experience loss of cognition, memory and independence, as well as psychological symptoms such as depression and anxiety.⁹ For care partners, witnessing the changes in their loved ones can be difficult and providing round-the-clock care can impact their own emotional well-being, employment and finances.^7,9

Eisai is working collaboratively with the National Institute for Health and Care Excellence, the Scottish Medicines Consortium and the National Health Service (NHS) to make this medicine available to eligible people living with early AD in Great Britain as soon as possible.

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. In Great Britain, Eisai and Biogen will co-promote the medicine, with Eisai distributing the product as the MA Holder.

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

**Protofibrils are thought to be the most toxic Aβ species that contribute to brain damage in AD and play a major role in the cognitive decline of this progressive and devastating disease. Protofibrils can cause neuronal damage in the brain, which can subsequently adversely affect cognitive function through multiple mechanisms.¹⁰ The mechanism by which this occurs has been reported not only by increasing the formation of insoluble Aβ plaques, but also by directly damaging signalling between neurons and other cells. It is believed that reducing protofibrils may reduce neuronal damage and cognitive impairment, potentially preventing the progression of AD.¹¹

^†CDR-SB is a commonly used diagnostic tool, which can help to stage dementia due to AD.¹² 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.¹²

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

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