The European Commission refers lecanemab decision to Appeal Committee

Rhea-AI Summary

BioArctic AB (BIOA) announced that the European Commission (EC) has referred the marketing authorization approval decision for lecanemab, their Alzheimer's treatment, to the Appeal Committee. This follows the positive opinion received from the Committee for Medicinal Products for Human Use (CHMP) in February 2025.

If approved, the authorization would extend to all 27 EU member states, plus Iceland, Liechtenstein, and Norway. The drug, marketed as Leqembi, is already approved in several major markets including the US, Japan, China, and Great Britain.

Leqembi was developed through a collaboration between BioArctic and Eisai, based on Professor Lars Lannfelt's discovery of the Arctic mutation in Alzheimer's disease. While Eisai manages clinical development and global commercialization, BioArctic retains rights to commercialize Leqembi in the Nordic region jointly with Eisai.

Positive

• Leqembi already approved in major markets (US, Japan, China, Great Britain)
• Positive CHMP opinion received in February 2025
• Potential market expansion to 30 European countries if approved

Negative

• Unexpected regulatory delay with EC referring decision to Appeal Committee
• EU market entry timeline now uncertain due to additional review process

Insights

Biotechnology Regulatory Analyst

The European Commission's referral of lecanemab (Leqembi) to the Appeal Committee introduces a procedural complication in BioArctic's EU approval journey. This step follows the Committee for Medicinal Products for Human Use (CHMP) reconfirming its positive opinion for the Alzheimer's treatment in February 2025.

While concerning on its face, this development represents more of a procedural uncertainty than an outright negative signal. The Appeal Committee referral suggests unresolved questions or concerns within the EC's Standing Committee, but doesn't necessarily indicate rejection. The article provides no explanation for why this referral occurred, making it difficult to assess the specific regulatory concerns.

Several factors mitigate the impact of this uncertainty:

• Leqembi has already secured approvals in multiple major markets including the US, Japan, China, and Great Britain
• The CHMP has twice issued positive opinions on the application
• BioArctic and Eisai continue preparations for joint Nordic region commercialization

For BioArctic, EU approval represents access to 27 member states plus Iceland, Liechtenstein, and Norway – a substantial market opportunity. The company's specific commercial interests focus on the Nordic region, where it maintains co-commercialization rights with partner Eisai.

This regulatory detour will likely delay the final EU approval decision, but considering the drug's existing approval in other sophisticated regulatory environments, the probability of ultimate approval remains favorable despite this procedural hurdle.

STOCKHOLM, April 1, 2025 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced that the European Commission (EC) has decided to refer the marketing authorisation approval decision of lecanemab in the EU to the Appeal Committee.

The final process for the EC decision on lecanemab's Marketing Authorisation Application (MAA) is underway, following the reconfirmation of the positive opinion for lecanemab's approval by the Committee for Medicinal Products for Human Use (CHMP) in February 2025. The EC announced that it has deliberated on the MAA in its Standing Committee and, based on the results of those deliberations, has referred the decision to the Appeal Committee in accordance with the EC review process.

If the marketing authorization application for lecanemab is approved, 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.

Leqembi is the result of a long-standing collaboration between BioArctic and Eisai, and the antibody was originally developed by BioArctic based on the work of Professor Lars Lannfelt and his discovery of the Arctic mutation in Alzheimer's disease. Eisai is responsible for the clinical development, applications for market approval and commercialization of Lecanemab for Alzheimer's disease. BioArctic has the right to commercialize Leqembi in the Nordic region together with Eisai and currently, the two companies are preparing for a joint commercialization in the region.  

This information is information that BioArctic AB (publ) is obliged to disclose pursuant to the EU Market Abuse Regulation. The information was released for public disclosure, through the agency of the contact persons below, on April 1, 2025, at 12:00 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, Senior Director Sustainability and Communications
E-mail: charlotte.afklercker@bioarctic.com
Phone: +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 lecanemab 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 under certain conditions 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.se.

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The European Commission refers lecanemab decision to Appeal Committee

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SOURCE BioArctic

FAQ

What is the current status of lecanemab's EU approval for BIOA?

The European Commission has referred lecanemab's approval decision to the Appeal Committee, following a positive CHMP opinion in February 2025.

In which markets is BIOA's Leqembi already approved?

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

What territories would be covered by EU approval of BIOA's lecanemab?

EU approval would cover all 27 European Union member states, plus Iceland, Liechtenstein, and Norway.

What are BIOA's commercialization rights for Leqembi?

BioArctic has rights to commercialize Leqembi in the Nordic region jointly with Eisai.