Sunday, February 9, 2025

Alzheimer’s: Update on Regulatory Review of Lecanemab for Early Alzheimer’s Disease in the European Union

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Eisai and Biogen announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion on the Marketing Authorization Application (MAA) for lecanemab, a humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody, as a treatment for early Alzheimer’s disease (AD), including mild cognitive impairment and mild Alzheimer’s disease.

“We are extremely disappointed by the CHMP’s negative opinion and understand that this may also be disappointing for the wider Alzheimer’s disease community. AD is an irreversible, neurodegenerative disease that poses significant challenges to those living with AD, their care partners, and society,” said Lynn Kramer, M.D., Chief Clinical Officer at Eisai. “There is a significant unmet need for new innovative treatment options that target an underlying cause of disease progression. We remain focused on making a meaningful difference to those living with early AD and those closest to them.”

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Alzheimer’s: Eisai to Seek Re-Examination of CHMP Opinion on Lecanemab, Already Approved in Multiple Countries

Despite this setback, Eisai plans to seek re-examination of the CHMP opinion and will work with the relevant authorities to ensure this treatment is available for eligible people living with early AD in the European Union (EU) as soon as possible. Lecanemab has already received approval in several countries, including the United States, Japan, China, South Korea, Hong Kong, and Israel, and is currently being marketed in the U.S., Japan, and China.

The prevalence of AD is substantial, with 6.9 million people currently affected in Europe. This number is expected to nearly double by 2050 due to the increasing aging population. The growing number of AD patients underscores the urgent need for effective treatments that address the underlying causes of the disease.

Eisai leads the global development and regulatory submissions for lecanemab, with both Eisai and Biogen co-commercializing and co-promoting the product. Eisai retains final decision-making authority on the commercialization strategies for lecanemab.

Lecanemab’s development has been driven by the significant unmet need for therapies that can modify the course of AD by targeting amyloid-beta, a protein believed to play a critical role in the pathogenesis of Alzheimer’s. Lecanemab is designed to reduce the soluble aggregated forms of amyloid-beta, potentially slowing disease progression and preserving cognitive function in patients with early AD.

The CHMP’s decision is a significant setback for the AD community, which has eagerly anticipated new treatment options. The need for innovative therapies that can alter the disease trajectory is more pressing than ever, as current treatments primarily focus on symptom management rather than modifying the underlying disease process.

Alzheimer’s

Alzheimer’s: Regulatory Landscape for AD Therapies Faces Challenges Despite Advancements

The regulatory landscape for AD therapies has been challenging, with many promising treatments facing hurdles in gaining approval. The complexity of AD, combined with the rigorous requirements for demonstrating clinical efficacy and safety, makes the approval process demanding. However, advancements in understanding the disease mechanisms and ongoing research efforts continue to drive the development of new potential treatments.

Eisai and Biogen remain committed to addressing the needs of AD patients and their families. The companies’ collaborative efforts aim to bring forward treatments that can provide meaningful benefits and improve the quality of life for those affected by this debilitating disease. The pursuit of re-examination by the CHMP reflects their determination to navigate regulatory challenges and ensure that promising therapies reach the patients who need them.

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In addition to regulatory efforts, ongoing clinical trials are exploring the potential of lecanemab in various stages of AD and different patient populations. These studies aim to provide further evidence of the drug’s efficacy and safety, which could support future regulatory submissions and approvals in other regions.

The global burden of Alzheimer’s disease is immense, and the projected increase in cases highlights the need for sustained investment in research and development. Governments, healthcare providers, and the pharmaceutical industry must continue to collaborate to address the challenges posed by AD and to ensure that innovative treatments are accessible to patients worldwide.

In conclusion, the CHMP’s negative opinion on lecanemab is a significant development in the regulatory journey of this promising AD treatment. Eisai and Biogen’s commitment to seeking re-examination and their ongoing efforts in clinical research underscore their dedication to finding effective solutions for Alzheimer’s disease. The continued pursuit of innovative therapies is crucial in the fight against AD, offering hope to millions of patients and their families affected by this relentless disease.

Resource: Biogen, July 26, 2024


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