The Committee for Medicinal Products for Human Use (CHMP) reaffirms positive opinion for Lecanemab in early Alzheimer's disease in the EU

Rhea-AI Summary

BioArctic AB (BIOA B) announced that the European Medicines Agency's CHMP has reaffirmed its positive opinion for lecanemab (Leqembi®) in early Alzheimer's disease, originally adopted in November 2024. This follows the European Commission's January 2025 request to review additional safety information and risk minimization measures clarity.

Leqembi, an anti-Aβ monoclonal antibody targeting toxic protofibrils and Aβ plaques, is already approved in the US, Japan, China, and Great Britain. If approved by the EC, the marketing authorization will extend to all 27 EU member states, Iceland, Liechtenstein, and Norway.

Positive

• CHMP reaffirmed positive opinion for Leqembi approval in EU
• Product already approved in major markets (US, Japan, China, UK)
• Potential market expansion to 30 European countries

Negative

• Additional safety review required by European Commission
• Marketing authorization still pending final EC approval

Insights

Financial Analyst

The CHMP's reaffirmation of its positive opinion for lecanemab represents a significant regulatory milestone for BioArctic and partner Eisai. This decision effectively removes a potential obstacle in the European approval pathway after the EC requested additional safety data review. With lecanemab already approved in the US, Japan, China, and Great Britain, EU authorization would complete global market access across all major pharmaceutical territories.

For BioArctic, a company with $150 million market capitalization, securing EU approval is disproportionately impactful compared to larger pharmaceutical companies. The EU market, encompassing 27 member states plus three additional countries, represents a substantial commercial opportunity, particularly given Europe's aging population demographics and rising Alzheimer's disease prevalence.

While specific partnership terms weren't disclosed in this announcement, BioArctic likely stands to benefit from milestone payments upon EU approval and subsequent royalties from European sales. This regulatory progress carries heightened significance for smaller biotech companies where individual product approvals can fundamentally transform financial trajectories. Investors should note that the CHMP's review of additional safety data resulting in no changes to their positive opinion effectively neutralizes a potential risk factor that could have delayed or complicated the approval process.

Medical Expert

Lecanemab represents a notable approach in Alzheimer's treatment through its selective targeting of toxic protofibrils - soluble amyloid beta aggregates that continue causing neuronal damage even after plaque reduction. This mechanistic distinction potentially addresses limitations of previous amyloid-targeting therapies.

The CHMP's safety review is particularly significant in the context of this drug class. Anti-amyloid antibodies have faced scrutiny regarding side effects including ARIA (Amyloid-Related Imaging Abnormalities), which can manifest as brain swelling or microhemorrhages. The committee's conclusion that no opinion update was needed suggests the safety profile remains acceptable within the benefit-risk framework established during clinical development.

From a medical perspective, having confirmed pathways to approval in all major markets creates consistent treatment availability for early Alzheimer's patients globally. The EU regulatory environment typically employs rigorous evaluation standards, making this reaffirmed positive opinion particularly meaningful. The emphasis on "early Alzheimer's disease" in the approval scope aligns with clinical evidence showing greater efficacy when these treatments are administered before significant disease progression, highlighting the importance of early diagnosis infrastructure alongside treatment availability.

STOCKHOLM, Feb. 28, 2025 /PRNewswire/ --  BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has reaffirmed its positive opinion for the anti-Aβ monoclonal antibody lecanemab (Leqembi®), adopted in November 2024. 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 authorisation.

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.

Leqembi is a Aβ monoclonal antibody that preferentially binds to toxic protofibrils (soluble Aβ aggregates), in addition to targeting and reducing Aβ plaques (insoluble Aβ aggregates). Aβ protofibrils are a key toxic form of Aβ that continue to accumulate in the brain and cause neuronal injury after plaque reduction.

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. Leqembi is already approved in the US, Japan, China, Great Britain and other markets. Eisai and BioArctic will continue to make every effort to deliver lecanemab to patients with early AD in as soon as possible.

This information is information that BioArctic is obliged to make public pursuant to the Financial Instruments Trading Act. The information was released for public disclosure, through the agency of the contact persons below, on February 28, 2025, at 14:00 CET.

For further information, please contact: 
Oskar Bosson, VP Communications and IR
E-mail: oskar.bosson@bioarctic.se 
Phone: +46 70 410 71 80
Charlotte af Klercker, Director Communications and Sustainability
E-mail: charlotte.afklercker@bioarctic.com
Telephone: +46 73 515 09 70

About lecanemab (Leqembi^®)

Lecanemab is the result of a strategic research alliance between BioArctic and Eisai. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). 

Lecanemab is approved in the U.S., Japan, China, United Kingdom, and several other markets for the treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD dementia. Lecanemab's approvals in these countries, as well as the CHMP's positive opinion in November 2024, were primarily based on Phase 3 data from Eisai's global Clarity AD clinical trial, in which it met its primary endpoint and all key secondary endpoints with statistically significant results. Eisai has also submitted applications for regulatory approval of lecanemab in several other countries and regions.

A supplemental Biologics License Application (sBLA) for less frequent intravenous maintenance dosing was approved by the U.S. Food and Drug Administration (FDA) in January 2025. In January 2025, the rolling submission of a Biologics License Application (BLA) for maintenance dosing of a subcutaneous auto injection formulation, which is being developed to enhance convenience for patients, was accepted in the U.S., with PDUFA date August 31, 2025. 

Since July 2020, Eisai's Phase 3 clinical study (AHEAD 3-45) with lecanemab in individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. The study was fully recruited in October 2024. AHEAD 3-45 is a four-year study 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 and Eisai. 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. 

About the collaboration between BioArctic and Eisai

Since 2005, BioArctic has a long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of Alzheimer's disease. The most important agreements are the Development and Commercialization Agreement for the lecanemab antibody, which was signed 2007, and the Development and Commercialization agreement for the antibody Leqembi back-up for Alzheimer's disease, which was signed 2015. In 2014, Eisai and Biogen entered into a joint development and commercialization agreement for lecanemab. Eisai is responsible for the clinical development, application for market approval and commercialization of the products for Alzheimer's disease. BioArctic has the right to commercialize lecanemab in the Nordic region and is currently preparing for commercialization in the Nordics together with Eisai. BioArctic has no development costs for lecanemab in Alzheimer's disease and is entitled to payments in connection with regulatory approvals, and sales milestones as well as royalties on global sales.

About BioArctic AB

BioArctic AB (publ) is a Swedish research-based biopharma company focusing on innovative treatments that can delay or stop the progression of neurodegenerative diseases. The company invented Leqembi® (lecanemab) - the world's first drug proven to slow the progression of the disease and reduce cognitive impairment in early Alzheimer's disease. Leqembi has been developed together with BioArctic's partner Eisai, who are responsible for regulatory interactions and commercialization globally. In addition to Leqembi, BioArctic has a broad research portfolio with antibodies against Parkinson's disease and ALS as well as additional projects against Alzheimer's disease. Several of the projects utilize the company's proprietary BrainTransporter™ technology, which has the potential to actively transport antibodies across the blood-brain barrier to enhance the efficacy of the treatment. BioArctic's B share (BIOA B) is listed on Nasdaq Stockholm Large Cap. For further information, please visit www.bioarctic.com.

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The Committee for Medicinal Products for Human Use (CHMP) reaffirms positive opinion for Lecanemab in early Alzheimer’s disease in the EU

 

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SOURCE BioArctic

FAQ

What is the current status of Leqembi's approval process for BIOA in the European Union?

CHMP has reaffirmed its positive opinion from November 2024, and the European Commission has resumed the decision-making process for marketing authorization.

In which markets is BIOA's Leqembi already approved as of February 2025?

Leqembi is currently approved in the US, Japan, China, Great Britain and other markets.

What specific concerns did the European Commission raise about BIOA's Leqembi in January 2025?

The EC requested review of new safety information and clarity of risk minimization measures in the CHMP opinion.

How many countries will BIOA's Leqembi marketing authorization cover if approved by the EC?

The approval will cover 30 countries: 27 EU member states plus Iceland, Liechtenstein, and Norway.