The Committee for Medicinal Products for Human Use (CHMP) Reaffirms Positive Opinion for Lecanemab in Early Alzheimer's Disease

Rhea-AI Summary

Eisai and Biogen (BIIB) announced that the European Medicines Agency's CHMP has reaffirmed its positive opinion for lecanemab, their anti-Aβ monoclonal antibody treatment for early Alzheimer's disease. This follows the European Commission's January 2025 request to review additional safety information that emerged after the initial November 2024 positive opinion.

The treatment targets an estimated 15.2 million people with mild cognitive impairment due to Alzheimer's and 6.9 million with AD dementia in Europe. If approved by the EC, lecanemab will be available in all 27 EU member states, plus Iceland, Liechtenstein, and Norway.

Lecanemab has already received approval in multiple regions including the US, Japan, China, and South Korea. The FDA recently approved a maintenance dosing schedule of once every four weeks, and a subcutaneous injection formulation is under review to enhance patient convenience.

Positive

• CHMP reaffirms positive opinion for EU approval
• Large potential market of 22.1M patients in Europe
• Already approved in 11 major markets globally
• FDA approved more convenient 4-week maintenance dosing
• New subcutaneous formulation under review for enhanced convenience

Negative

• Additional safety review required by European Commission
• Final EU approval still pending

Insights

Pharmaceutical Industry Analyst

The CHMP's reaffirmation of its positive opinion for lecanemab represents a significant regulatory milestone for Biogen and Eisai in their pursuit of European approval for this Alzheimer's treatment. This development effectively clears a critical hurdle after the European Commission requested additional safety information review in January 2025.

With 15.2 million people suffering from mild cognitive impairment due to Alzheimer's and 6.9 million with AD dementia across Europe, the potential market opportunity is substantial. European approval would expand lecanemab's global footprint beyond its existing approvals in major markets including the US, Japan, China, and the UK.

The timing is particularly favorable following the FDA's January 2025 approval of a more convenient once-every-four-weeks maintenance dosing regimen. The pending application for a subcutaneous formulation further demonstrates the companies' commitment to enhancing patient convenience and potentially expanding the addressable market.

This collaborative arrangement between Eisai and Biogen, with Eisai leading development while both share commercialization responsibilities, represents a strategic approach to bringing this complex therapy to market while managing development costs and commercial execution.

Neuroscience Medical Expert

Lecanemab's progress toward European approval is noteworthy in the Alzheimer's treatment landscape. As a humanized IgG1 monoclonal antibody targeting both soluble protofibrils and insoluble forms of amyloid-beta, its mechanism represents the culmination of decades of research into the amyloid hypothesis of Alzheimer's disease.

The focus on early Alzheimer's disease (mild cognitive impairment due to AD and mild dementia) is particularly significant as it targets the disease when intervention may be most impactful. The CHMP's review of additional safety information is an expected part of the regulatory process for an amyloid-targeting therapy, which has required careful risk management strategies in other markets.

The ongoing research programs including the AHEAD 3-45 study for preclinical AD and the Tau NexGen study for Dominantly Inherited AD demonstrate how lecanemab is being positioned not just as a treatment but potentially as a foundation for combination approaches, particularly as lecanemab serves as the "backbone anti-amyloid therapy" in the Tau NexGen trial.

The public-private partnerships supporting these trials, including collaboration with academic institutions and the National Institute on Aging, highlight the comprehensive approach being taken to advance understanding of this complex disease.

TOKYO and CAMBRIDGE, Mass., Feb. 28, 2025 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has reaffirmed its positive opinion by consensus for the anti-Aβ monoclonal antibody lecanemab, adopted in November 2024.¹ Following CHMP's reaffirmation, after having considered the additional information requested by the European Commission (EC), the EC will resume the decision-making process for lecanemab's marketing authorization.

In January 2025, as part of its decision-making process, the EC asked the CHMP to consider information on the safety of lecanemab that became available after the adoption of the CHMP opinion in November 2024 and whether this may require an update of the opinion, and to consider whether the wording of the risk minimization measures in the opinion is clear enough to ensure correct implementation. After reviewing the additional information, the CHMP concluded that its positive opinion for lecanemab does not need to be updated.

Mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and AD dementia currently affects an estimated 15.2 million and 6.9 million people in Europe, respectively.² AD progresses over time in stages with increasingly severe symptoms that greatly impact not only those who are living with AD, but also their loved ones, care partners and society. There is a significant unmet need for new treatment options that slow down the progression of AD from its early stage.

If the EC approves the lecanemab marketing authorization application, the approval will apply to all 27 European Union member states, as well as Iceland, Liechtenstein, and Norway. Eisai and Biogen will continue to make every effort to deliver lecanemab to patients with early AD in Europe as soon as possible.

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

Notes to Editors

1. About lecanemab (generic name, brand name: Leqembi^®)
Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ).

Lecanemab has been approved in the U.S.,³ Japan,⁴ China,⁵ South Korea,⁶ Hong Kong,⁷ Israel,⁸ the United Arab Emirates,⁹ the United Kingdom,¹⁰ Mexico,¹¹ Macau and Oman, and is under regulatory review in 18 countries and regions including the EU. In January 2025, the U.S. Food and Drug Administration (FDA) has approved the Supplemental Biologics License Application (sBLA) for once every four weeks maintenance dosing. In January 2025, the submission of a Biologics License Application (BLA) for maintenance dosing of a subcutaneous injection formulation, which is being developed to enhance convenience for patients, was accepted in the U.S.

Since July 2020 the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health, Eisai and Biogen. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy.

2. About the Collaboration between Eisai and Biogen for AD
Eisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. Eisai serves as the lead of lecanemab development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority.

3. About the Collaboration between Eisai and BioArctic for AD
Since 2005, Eisai and BioArctic have had a long-term collaboration regarding the development and commercialization 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 commercialization agreement on the antibody lecanemab back-up was signed in May 2015.

4. About Eisai Co., Ltd.
Eisai's Corporate Concept is "to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides." Under this Concept (also known as human health care (hhc) Concept), we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.

In addition, we demonstrate our commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), by working on various activities together with global partners.

For more information about Eisai, please visit www.eisai.com (for global headquarters: Eisai Co., Ltd.), and connect with us on X, LinkedIn and Facebook. The website and social media channels are intended for audiences outside of the UK and Europe. For audiences based in the UK and Europe, please visit www.eisai.eu and Eisai EMEA LinkedIn.

5. 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 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.

The company routinely posts information that may be important to investors on its website at www.biogen.com. Follow Biogen on social media – Facebook, LinkedIn, X, YouTube.

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 Alzheimer's disease; the anticipated benefits and potential of Biogen's collaboration arrangements with Eisai; the potential of Biogen's commercial business and pipeline programs, including  lecanemab; and risks and uncertainties associated with drug development and commercialization. These statements may be identified by words such as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "may," "plan," "possible," "potential," "will," "would" and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical studies may not be indicative of full results or results from later stage or larger scale clinical studies and do not ensure regulatory approval. You should not place undue reliance on these statements.

These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation unexpected concerns that may arise from additional data, analysis or results obtained during clinical studies; the occurrence of adverse safety events; risks of unexpected costs or delays; the risk of other unexpected hurdles; regulatory submissions may take longer or be more difficult to complete than expected; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of Biogen's drug candidates, including lecanemab; actual timing and content of submissions to and decisions made by the regulatory authorities regarding lecanemab; uncertainty of success in the development and potential commercialization of lecanemab; failure to protect and enforce Biogen's data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; product liability claims; and third party collaboration risks, results of operations and financial condition. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Biogen's expectations in any forward-looking statement. Investors should consider this cautionary statement as well as the risk factors identified in Biogen's most recent annual or quarterly report and in other reports Biogen has filed with the U.S. Securities and Exchange Commission. These statements speak only as of the date of this news release. Biogen does not undertake any obligation to publicly update any forward-looking statements.

References

1. Committee for Medicinal Products for Human Use. 2024. Leqembi (Lecanemab).
   Overview. Available at:  https://www.ema.europa.eu/en/medicines/human/EPAR/leqembi#overview. Last accessed: January 2025.
2. Gustavsson, A., et al. Global estimates on the number of persons across the Alzheimer's disease continuum. Alzheimer's & Dementia. 2023;19:658-670. https://alz-journals.onlinelibrary.wiley.com/doi/full/10.1002/alz.12694.
3. U.S. Food and Drug Administration. 2023. FDA Converts Novel Alzheimer's Disease Treatment to Traditional Approval. Last accessed: January 2025.
4. Reuters. 2023. Japan approves Alzheimer's treatment Leqembi by Eisai and Biogen. Last accessed: January 2025.
5. The Pharma Letter. 2024. Brief - Alzheimer drug Leqembi now approved in China. Last accessed: January 2025.
6. Pharmaceutical Technology. 2024. South Korea's MFDS approves Eisai-Biogen's LEQEMBI for Alzheimer's. Last accessed: January 2025.
7. Pharmaceutical Technology. 2024. Hong Kong approves Leqembi for Alzheimer's treatment. Last accessed: January 2025.
8. Pharmaceutical Business Review. 2024. Leqembi gains approval for Alzheimer's treatment in Israel. Last accessed: January 2025.
9. United Arab Emirates Ministry of Health & Prevention. 2024. Registered Medical Product Directory. Leqembi. Last accessed: January 2025.
10. Lecanemab United Kingdom Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/15908. Last accessed: January 2025.
11. The Pharma Letter. 2024. BRIEF-Mexican approval for Alzheimer's drug Leqembi. Available at: https://www.thepharmaletter.com/brief-mexican-approval-for-alzheimers-drug-leqembi. Last accessed: January 2025.

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SOURCE Eisai Inc.

FAQ

What is the current status of lecanemab's approval process in Europe for BIIB?

CHMP has reaffirmed its positive opinion for lecanemab in February 2025, following additional safety review requested by the European Commission in January 2025.

How many European patients could potentially benefit from BIIB's lecanemab treatment?

An estimated 22.1 million Europeans could benefit, including 15.2 million with mild cognitive impairment due to Alzheimer's and 6.9 million with AD dementia.

Which countries have already approved BIIB's lecanemab for Alzheimer's treatment?

Lecanemab is approved in the US, Japan, China, South Korea, Hong Kong, Israel, UAE, UK, Mexico, Macau, and Oman, with pending reviews in 18 other countries.

What new dosing options has BIIB received FDA approval for lecanemab?

In January 2025, the FDA approved a maintenance dosing schedule of once every four weeks, and is reviewing a new subcutaneous injection formulation.