The Scottish Medicines Consortium (SMC) has announced that following a Fast Track Resubmission by Eisai, Leqembi® (lecanemab) has not been recommended for use in the National Health Service (NHS) in Scotland1

The Scottish Medicines Consortium (SMC) has announced that following a Fast Track Resubmission by Eisai, Leqembi^®  (lecanemab) has not been recommended for use in the National Health Service (NHS) in Scotland¹

HATFIELD, HERTFORDSHIRE, UNITED KINGDOM (UK), and MAIDENHEAD, UK, 7 JULY 2025 – Eisai Europe Ltd. and Biogen Idec Ltd. announced today that the Scottish Medicines Consortium (SMC) has not recommended Leqembi^® (lecanemab) for use in its licensed indication in the National Health Service (NHS) in Scotland, following a Fast Track Resubmission by Eisai.¹ Lecanemab was authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease (early Alzheimer’s disease) in adult patients that are apolipoprotein E ε4 (ApoE ε4)* heterozygotes or non-carriers on 22 August 2024.⁴

Senior Eisai executives have issued the following statements. 

Shaeed Chowdhury, Medical Director, Eisai UK and Ireland, said,

“Alzheimer’s is a progressive disease that worsens over time, robbing people of their memory, independence and ultimately dignity.⁵ For people affected by Alzheimer’s disease, being able to maintain independence and mental and physical wellbeing for as long as possible is important.⁶ However, current treatments available on the NHS are not able to slow down the progression of Alzheimer’s disease, and instead focus on managing symptoms of the disease.¹ This is the first medicine to be approved in the UK that targets an underlying cause of the disease.^3,4 The medicine was approved by the MHRA after meeting its comprehensive assessment criteria.^4,7 We are deeply saddened by the SMC’s decision not to recommend access to lecanemab for eligible NHS patients in Scotland.”

“Eisai submitted data from the Clarity AD clinical trial for the UK indicated population to the SMC as part of their review, which demonstrated that lecanemab statistically significantly slowed down the progression of early Alzheimer’s disease through the trial’s primary endpoint^†, which collectively measured memory, orientation, judgement and problem solving, community affairs, home and hobbies, and personal care.⁴”

“There is a significant need to address the earlier stages of disease,⁸ and without early intervention, patients may miss out on potential treatments that slow the progression of the disease.”

“At Eisai, we firmly believe that each day without real change in the management of Alzheimer’s disease incurs a greater emotional and financial cost for patients and their families, as well as imposing increased strain and pressure on the NHS and society.”

In the Clarity AD clinical trial, the most common adverse reactions in the UK indicated population were infusion-related reaction, amyloid-related imaging abnormalities with haemosiderin deposition (small spots of bleeding) (ARIA-H), fall, headache and amyloid-related imaging abnormalities with cerebral oedema (build-up of fluid) (ARIA-E).⁴

Nick Burgin, President and COO President Global Value & Access, Eisai EMEA, said,

“We categorically stand by the clinical and cost-effectiveness of lecanemab in its licensed indication⁴ and that there is a need to change the way that early Alzheimer’s disease is managed. The SMC has flexibility in its assessment and no formal cost-effectiveness thresholds,^9,10,11 so the decision not to provide the medicine on the NHS in Scotland has left us frustrated and confused. We believe there could have been a better outcome if there was willingness to embrace early interventions and prioritise early Alzheimer's disease patients within the Scottish healthcare system.”

“Lecanemab is the first Alzheimer’s treatment to be approved in the UK in two decades^4,12 and unlike symptomatic treatments, it has the potential to slow down the progression of early Alzheimer’s disease for the first time.^3,4 As part of the SMC’s review process, they are able to consider additional factors, known as modifiers, to enable great flexibility in the SMC decision making processes.¹¹ One of these modifiers is whether there is an absence of other therapeutic options of proven benefits provided by the NHS.¹¹ The SMC decided not to apply a modifier in its assessment of lecanemab. This is even more pertinent as, when the impact of caregiver burden was included in the assessment, the cost-effectiveness of the medicine was determined to be even more favourable.¹”

“This represents a missed opportunity to consider the benefit and innovation of a medicine for a condition as serious as Alzheimer’s disease,” added Nick.

Gary Hendler, Regional Chairman and CEO, Eisai EMEA, Senior Vice President & Global Corporate Officer, Eisai Co. Ltd, Tokyo, said,

“Today’s decision means more time waiting for answers for many people in Scotland who are impacted by early Alzheimer’s disease.”

“We’re calling on the Scottish Government to urgently prioritise new Alzheimer’s interventions for those patients and families affected. Although Scotland aims to be recognised as a leader in dementia policy,² proactively investing in policies and services, which positions it favourably to deliver innovative treatments, it has missed an opportunity to provide an innovative medicine to eligible patients via the NHS. By not making emerging treatments available, Eisai feels the SMC is not maximising the investments that have been made into dementia policies and health services.”

“A key part of the 10-year Dementia Strategy published by the Scottish Government and Convention of Scottish Local Authorities (COSLA) includes the vision that people living with dementia, their families and care partners/unpaid carers are supported to live an independent life, and embraces a person-centred approach to providing support, treatment and care, when and where it is needed.¹³”

“We believe that by deciding not to provide the medicine through the NHS, Scotland is not delivering all that it can against these ambitions,” added Gary. “We’re committed to supporting eligible patients to access the medicine through the NHS and exploring all possible avenues as we work towards improving the future delivery of new Alzheimer’s disease medicines.”

The SMC announced its initial decision not to reimburse lecanemab in February 2025. Since then, Eisai has worked closely with the SMC to complete a Fast Track Resubmission and enable patient access. Eisai remains committed to ongoing collaboration with the Scottish Government, SMC and NHS Scotland to make this a reality in the future.

*Apolipoprotein E is a protein involved in the metabolism of fats in humans. It is implicated in Alzheimer’s disease.¹⁴

^†Clinical Dementia Rating Sum of Boxes (CDR-SB) is a diagnostic tool, which can help to stage dementia due to AD.¹⁵ 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.¹⁵

Reporting of side effects:

: This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play and Apple App store. By reporting side effects, you can help provide more information on the safety of this medicine.

Notes to editors:

1. About lecanemab

Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanised immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ).^3,4 The medicine is authorised in the U.S.,¹⁶ Japan,¹⁷ China,¹⁸ South Korea,¹⁹ Hong Kong,²⁰ Israel,²¹ the United Arab Emirates,²² the UK,⁴ Mexico,²³ Macau, Oman, Taiwan,²⁴ the European Union, ²⁵ Qatar and Singapore, and is under regulatory review in 12 countries and regions.²⁴

Lecanemab’s approval was primarily based on Phase 3 data from Eisai’s global Clarity AD clinical trial, in which the medicine met its primary endpoint and all key secondary endpoints with statistically significant results.^3,4 Clarity AD was a Phase 3 global, placebo-controlled, double-blind, parallel-group, randomised study in 1,795 patients with early Alzheimer’s disease (MCI or mild dementia due to Alzheimer’s disease, with confirmed presence of amyloid pathology), of which 1,521 were in the UK indicated population (ApoE ε4 heterozygotes or non-carriers).^3,4 The treatment group was administered lecanemab 10 mg/kg bi-weekly, with participants allocated in a 1:1 ratio to receive either placebo or lecanemab for 18 months.³

The primary endpoint was the global cognitive and functional scale, CDR-SB.⁴ In the Clarity AD clinical trial, treatment with lecanemab, in the UK indicated population (ApoE ε4 heterozygotes or non-carriers), reduced clinical decline on CDR-SB by 33% at 18 months compared to placebo.⁴ The mean CDR-SB score at baseline was approximately 3.2 in both groups.⁴ The adjusted least-squares mean change from baseline at 18 months was 1.15 with lecanemab and 1.73 with placebo (difference, −0.58; 95% confidence interval [CI], −0.81 to −0.35; P<0.00001) in the indicated population.⁴ CDR-SB 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.¹⁵

In addition, the secondary endpoint from the AD Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-MCI-ADL), which measures information provided by people caring for patients with AD, noted 39% less decline compared to placebo at 18 months.⁴ The adjusted mean change from baseline at 18 months in the ADCS-MCI-ADL score was −3.5 in the lecanemab group and −5.7 in the placebo group (difference, 2.2; 95% CI, 1.3 to 3.1; P<0.00001).⁴ The ADCS-MCI-ADL assesses the ability of patients to function independently, including being able to dress, feed themselves and participate in community activities.²⁶

In the UK indicated population (ApoE ε4 heterozygotes or non-carriers), the most common adverse reactions were infusion-related reaction (26%), ARIA-H (13%), fall (11%), headache (11%) and ARIA-E (9%).⁴

1. About the Collaboration between Eisai and Biogen for AD

Eisai and Biogen have been collaborating on the joint development and commercialisation of AD treatments since 2014. Eisai serves as the lead of lecanemab development and regulatory submissions globally with both companies co-commercialising and co-promoting the product and Eisai having final decision-making authority.

1. About the Collaboration between Eisai and BioArctic for AD

Since 2005, Eisai and BioArctic have had a long-term collaboration regarding the development and commercialisation of AD treatments. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement with BioArctic in December 2007. The development and commercialisation agreement on the antibody back-up was signed in May 2015.

1. About Eisai EMEA

At Eisai, we give our first thought to patients, their care partners and to society, to increase the benefits health care provides them – we call this human health care (hhc). We focus beyond the realm of health to the value we bring to society. Through the power of collaboration and by using insights to guide our work, we can make a meaningful contribution to people and society, and to improve outcomes and services for all.

In EMEA, we are the European hub of Tokyo-based Eisai Co. Ltd., forming part of a multinational team working across a global network of R&D facilities, manufacturing sites and marketing subsidiaries. 

Our collective passion and dedication to patient care is the driving force behind our efforts to discover and develop innovative medicines in a variety of therapeutic areas where a high unmet medical need remains, including oncology and neurology.

Our mission is clear; we strive to make a significant long-lasting contribution to society in an ethical, compliant, and sustainable way by embodying hhc in everything we do.

For more information about Eisai in the EMEA region please visit www.eisai.eu.

1. About Biogen

Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patient’s lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities with aspirations to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth.

Biogen routinely post information that may be important to investors on its website.

Biogen Safe Harbor

This news release contains forward-looking statements, including about the potential clinical effects of lecanemab; the potential benefits, safety and efficacy of lecanemab; potential regulatory discussions, submissions and approvals and the timing thereof; the treatment of AD; the anticipated benefits and potential of Biogen's collaboration arrangements with Eisai; the potential of Biogen's commercial business and pipeline programmes, including  lecanemab; and risks and uncertainties associated with drug development and commercialisation. These forward-looking statements may be accompanied by such words as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “forecast,” “goal,” “guidance,” “hope,” “intend,” “may,” “objective,” “plan,” “possible,” “potential,” “predict,” “project,” “prospect,” “should,” “target,” “will,” “would,” and other words and terms of similar meaning.  Drug development and commercialisation involve a high degree of risk, and only a small number of research and development programmes result in commercialisation of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements. Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such statements. These forward-looking statements are based on management's current beliefs and assumptions and on information currently available to management. Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realised in whole or in part. We caution that these statements are subject to risks and uncertainties, many of which are outside of our control and could cause future events or results to be materially different from those stated or implied in this document, including, among others, uncertainty of long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; expectations, plans and prospects relating to product approvals, approvals of additional indications for our existing products, sales, pricing, growth, reimbursement and launch of our marketed and pipeline products; our ability to effectively implement our corporate strategy; the successful execution of our strategic and growth initiatives, including acquisitions; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; the occurrence of adverse safety events, restrictions on use with our products, or product liability claims; and any other risks and uncertainties that are described in other reports we have filed with the U.S. Securities and Exchange Commission.

These statements speak only as of the date of this press release and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialise or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in our subsequent reports on Form 10-Q and Form 10-K, in each case including in the sections thereof captioned “Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in our subsequent reports on Form 8-K. Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise.

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