Eisai will seek re-examination of CHMP opinion för lecanemab

Rhea-AI Summary

BioArctic AB's partner Eisai announced plans to request re-examination of the Committee for Medicinal Products for Human Use (CHMP)'s negative opinion on the Marketing Authorization Approval for lecanemab, an Alzheimer's disease treatment, in the EU. The decision disappoints BioArctic's CEO, Gunilla Osswald, who emphasizes the importance of timely treatment for patients. Eisai has a 60-day period to provide grounds for re-examination, with CHMP having 60 days to respond.

Lecanemab is already approved in several countries, including the US, Japan, and China. Alzheimer's disease affects 6.9 million people in Europe, with projections indicating this number may double by 2050. BioArctic retains commercialization rights in the Nordic region, pending European approval.

Positive

• Lecanemab is already approved in multiple countries including the US, Japan, and China
• BioArctic has commercialization rights for lecanemab in the Nordic region, pending EU approval
• Eisai and BioArctic are preparing for joint commercialization in the Nordic region

Negative

• CHMP issued a negative opinion on lecanemab's Marketing Authorization Approval in the EU
• Delay in potential EU market entry for lecanemab due to re-examination process
• Potential loss of market opportunity in Europe's growing Alzheimer's disease patient population

Insights

Pharmaceutical Industry Analyst

The CHMP's negative opinion on lecanemab's Marketing Authorization Approval (MAA) in the EU is a significant setback for Eisai and BioArctic. This decision, while not final, could substantially delay the drug's availability in a important market. The EU represents a sizable opportunity, with 6.9 million Alzheimer's patients, expected to nearly double by 2050.

The re-examination process, while offering a second chance, introduces uncertainty and potential delays. This could impact BioArctic's revenue projections, especially considering their commercialization rights in the Nordic region. However, lecanemab's approvals in other major markets like the US, Japan and China provide some cushion.

Investors should note that this setback is primarily a timing issue rather than a fundamental challenge to the drug's efficacy. The strong existing approvals in other regions suggest that lecanemab's long-term prospects remain intact. Nevertheless, this delay could open a window for competitors in the EU market.

From a financial perspective, while immediate EU revenues are now uncertain, the global rollout in approved markets should continue to drive growth. The stock may face short-term pressure, but the long-term thesis for BioArctic remains largely unchanged, albeit with increased regulatory risk in Europe.

Regulatory Affairs Specialist

The CHMP's negative opinion on lecanemab is unusual given the drug's approval in several other major markets. This divergence highlights the complex regulatory landscape for Alzheimer's treatments in the EU. The re-examination process, while offering a path forward, is not a guarantee of reversal.

Key factors to watch in the re-examination:

• New rapporteurs will be assigned, potentially bringing fresh perspectives.
• Eisai has 60 days to provide grounds for re-examination, allowing them to address specific CHMP concerns.
• The CHMP then has another 60 days to respond, making this a potentially lengthy process.

This situation underscores the importance of robust, region-specific regulatory strategies. Eisai and BioArctic may need to provide additional data or analyses tailored to European regulatory requirements. The outcome of this process could have broader implications for the approval pathway of future Alzheimer's treatments in the EU.

For investors, this highlights the inherent risks in the drug approval process, even for treatments that have gained approval elsewhere. It also emphasizes the value of geographic diversification in drug approvals, as seen with lecanemab's success in other markets.

Neurology Research Expert

The CHMP's negative opinion on lecanemab is a surprising development given the drug's demonstrated efficacy in clinical trials and its approval in other major markets. This decision raises questions about the specific criteria and evidence thresholds being applied by European regulators for Alzheimer's treatments.

Lecanemab's mechanism of action, targeting amyloid beta plaques, represents a significant advance in Alzheimer's treatment. Its ability to delay the onset of more severe stages of the disease is a important benefit for patients, potentially extending their quality of life and reducing caregiver burden.

The delay in EU approval could have serious implications for Alzheimer's patients in Europe. With the disease affecting 6.9 million people and projected to nearly double by 2050, timely access to effective treatments is critical. Each year of delay potentially impacts millions of patients and their families.

From a research perspective, this decision might influence the direction of Alzheimer's drug development in Europe. It could potentially shift focus towards alternative treatment approaches or necessitate more extensive European-specific trials for amyloid-targeting therapies.

While the re-examination offers hope, the scientific community and patients alike will be eagerly awaiting the outcome, as it could significantly impact the landscape of Alzheimer's treatment in Europe.

STOCKHOLM, July 26, 2024 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that they will request re-examination of the Committee for Medicinal Products for Human Use (CHMP's) negative opinion posted today on the Marketing Authorization Approval (MAA) for lecanemab as treatment for Alzheimer's disease in the EU.

"We are surprised and very disappointed by the CHMP's opinion posted today. Foremost  the negative opinion adopted by the CHMP is sad for all patients, caregivers and healthcare professionals in the EU who will now have to wait longer for a treatment which can effectively change the course of this devastating disease. We know that for these patients, time is what they value the most, and potentially denying them a treatment which has been shown to delay the onset of more severe stages of the diseases is of course not what they or we had hoped for," said Gunilla Osswald, BioArctic's CEO. "This is not the final verdict however, and our partner Eisai will seek re-examination of the CHMP opinion and continue work with authorities to ensure this treatment is available for eligible people living with early Alzheimer's disease in the EU as soon as possible."

A formal request for re-examination allows the applicant a 60-day period to provide the CHMP with the grounds for the re-examination request. The CHMP, led by new rapporteurs, will have 60 days to respond.

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.

Alzheimer's disease currently affects 6.9 million people in Europe,^[1] and this figure is expected to nearly double by 2050 as aging populations increase.^[2] 

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 13:15 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.

^[1] European Medicines Agency. Involvement of patients in Scientific Advisory Group and Ad Hoc Expert meetings at EMA. Available at: https://www.ema.europa.eu/system/files/documents/other/involvement_of_patients_in_scientific_advisory_group-en.pdf. Last accessed: June 2024.

^[2] European Medicines Agency. The Centralised Procedure at the EMA. Available at: https://www.ema.europa.eu/en/documents/presentation/presentation-centralised-procedure-european-medicines-agency_en.pdf. Last accessed: June 2024.

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Eisai will seek re-examination of CHMP opinion för lecanemab

 

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SOURCE BioArctic

FAQ

What was the CHMP's decision on lecanemab for Alzheimer's disease treatment in the EU?

The Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion on the Marketing Authorization Approval for lecanemab as an Alzheimer's disease treatment in the EU.

How is Eisai responding to the CHMP's negative opinion on lecanemab (BIOA)?

Eisai announced plans to request a re-examination of the CHMP's negative opinion on lecanemab within the 60-day period allowed for providing grounds for re-examination.

In which countries is lecanemab (BIOA) already approved for Alzheimer's disease treatment?

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.

What are BioArctic's (BIOA) commercialization rights for lecanemab in Europe?

BioArctic has the right to commercialize lecanemab in the Nordic region, pending European approval. Eisai and BioArctic are preparing for joint commercialization in this region.