CHMP has adopted a negative opinion on lecanemab for the EU

Rhea-AI Summary

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion on BioArctic AB's partner Eisai's Marketing Authorization Approval (MAA) for lecanemab, a treatment for Alzheimer's disease. This decision affects BioArctic's (Nasdaq Stockholm: BIOA B) potential to commercialize lecanemab in the Nordic region, which was contingent on European approval.

Lecanemab is already approved and marketed in several countries, including the United States, Japan, and China. BioArctic is consulting with Eisai regarding future actions and will provide an update later today. The negative opinion from CHMP represents a significant setback for BioArctic's European market plans for lecanemab in Alzheimer's disease treatment.

Positive

• Lecanemab is already approved and marketed in multiple countries including the US, Japan, and China
• BioArctic has the right to commercialize lecanemab in the Nordic region, pending European approval

Negative

• CHMP adopted a negative opinion on Eisai's Marketing Authorization Approval for lecanemab in the EU
• The negative opinion affects BioArctic's potential to commercialize lecanemab in the Nordic region
• European market entry for lecanemab is now uncertain or delayed

Insights

Pharmaceutical Industry Analyst

The CHMP's negative opinion on lecanemab for the EU market is a significant setback for BioArctic and Eisai. This decision could have substantial implications for both companies' European market strategies and revenue projections.

Key points to consider:

• Lecanemab's approval in major markets like the US, Japan and China suggests its potential. The EU rejection raises questions about differing regulatory standards or data interpretations.
• The Nordic region commercialization plans for BioArctic are now in jeopardy, potentially impacting future revenue streams.
• Eisai's next steps, such as appealing the decision or conducting additional studies, will be important for the drug's future in Europe.
• This setback might affect investor confidence in BioArctic's pipeline and partnership strategy.

While the negative opinion is a blow, it's important to note that lecanemab is already generating revenue in other major markets. The overall impact on BioArctic will depend on the EU market's significance in their global strategy and their ability to address CHMP's concerns.

Neurology Specialist

The CHMP's negative opinion on lecanemab is a surprising development, given its approval in other major markets. This decision raises important questions about the drug's efficacy and safety profile in the context of European standards.

From a clinical perspective:

• The divergence in regulatory decisions between the EU and other regions suggests potential differences in data interpretation or risk-benefit assessment.
• This could reflect variations in patient populations, treatment protocols, or specific concerns about the drug's mechanism of action.
• The decision might also indicate a more cautious approach by European regulators towards new Alzheimer's treatments, given the complex nature of the disease and previous disappointments in this therapeutic area.

For Alzheimer's patients in Europe, this decision delays access to a potentially beneficial treatment. However, it also underscores the importance of rigorous safety and efficacy standards in neurodegenerative disease therapies. The scientific community will be keen to understand the specific reasons behind CHMP's negative opinion to guide future research and development efforts in this critical field.

Market Access Strategist

The CHMP's negative opinion on lecanemab presents a complex challenge for BioArctic and Eisai's European market access strategy. This decision will have ripple effects across their commercialization plans and potentially impact their global positioning.

Strategic implications to consider:

• BioArctic's plans for Nordic region commercialization are now on hold, necessitating a reassessment of their European market entry strategy.
• The companies may need to allocate additional resources for potential resubmission or new clinical trials tailored to European regulatory requirements.
• This setback could lead to a reevaluation of pricing strategies in other markets, as European pricing often serves as a reference for global pricing decisions.
• Competitors in the Alzheimer's space may gain an advantage in the European market, potentially altering the competitive landscape.

The path forward will likely involve intensive engagement with EMA to understand the specific concerns and determine the most efficient route to potential approval. This process could involve additional data analysis, new studies, or changes in the proposed indication. The companies' ability to navigate this setback will be important for their long-term success in the European Alzheimer's treatment market.

STOCKHOLM, July 26, 2024 /PRNewswire/ -- The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has today communicated that it has adopted a negative opinion on BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai's Marketing Authorization Approval (MAA) for lecanemab as treatment for Alzheimer's disease. BioArctic is currently consulting Eisai regarding forthcoming actions. A further update will be communicated later today.

Lecanemab is already approved in the United States, Japan, China, South Korea, Hong Kong, and Israel and is being marketed in the U.S., Japan and China.

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 lecanemab in the Nordic region, pending European approval, and currently Eisai and BioArctic 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 July 26, 2024, at 12:40 p.m. CET.

For further information, please contact: 
Oskar Bosson, VP Communications and IR
E-mail: oskar.bosson@bioarctic.se
Phone: +46 70 410 71 80 

About lecanemab (generic name, brand name: 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, South Korea, Hong Kong and Israel as treatment for early Alzheimer's disease (mild cognitive impairment and mild dementia due to Alzheimer's disease).

Lecanemab approvals were based on the large global Phase 3 Clarity AD study. In the Clarity AD study, lecanemab met its primary endpoint and all key secondary endpoints with statistically significant results. In November 2022, the results of the Clarity AD study were presented at the 2022 Clinical Trials on Alzheimer's Disease (CTAD) conference, and simultaneously published in the New England Journal of Medicine, a peer-reviewed medical journal.

Eisai has also submitted applications for approval of lecanemab in 11 other countries and regions, including the European Union (EU). A supplemental Biologics License Application (sBLA) for intravenous maintenance dosing was submitted to the U.S. Food and Drug Administration (FDA) in March 2024. The rolling 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 initiated in the U.S. under Fast Track status in May 2024. 

Since July 2020 Eisai's 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 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 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.com.

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CHMP has adopted a negative opinion on lecanemab for the EU

 

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SOURCE BioArctic

FAQ

What decision did the CHMP make regarding lecanemab for Alzheimer's treatment?

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a negative opinion on Eisai's Marketing Authorization Approval (MAA) for lecanemab as a treatment for Alzheimer's disease in the EU.

How does the CHMP decision affect BioArctic AB (BIOA)?

The negative opinion affects BioArctic's potential to commercialize lecanemab in the Nordic region, which was contingent on European approval. This represents a setback for BioArctic's European market plans for the Alzheimer's treatment.

In which countries is lecanemab already approved and marketed as of July 26, 2024?

As of July 26, 2024, lecanemab is approved in the United States, Japan, China, South Korea, Hong Kong, and Israel. It is currently being marketed in the U.S., Japan, and China.

What are BioArctic's (BIOA) next steps following the CHMP's negative opinion on lecanemab?

BioArctic is currently consulting with its partner Eisai regarding forthcoming actions. The company has stated that a further update will be communicated later on July 26, 2024.