Lecanemab (Leqembi®) is an innovative antibody intravenous (IV) infusion therapy that has garnered traditional approval from the U.S. Food and Drug Administration (FDA) for the treatment of early Alzheimer's disease. This groundbreaking treatment specifically targets and removes beta-amyloid plaques from the brain, a hallmark of Alzheimer's pathology. It is designed for individuals living with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease, who have confirmed elevated levels of beta-amyloid in their brains. By lowering beta-amyloid, Leqembi aims to reduce cognitive and functional decline, offering patients more time to participate in daily life and live independently.

Mechanism of Action and Administration

Lecanemab works by targeting beta-amyloid plaques, which are abnormal protein deposits that accumulate in the brains of Alzheimer's patients. These plaques are believed to disrupt cell function and trigger a cascade of events leading to neurodegeneration. By binding to these plaques, lecanemab facilitates their removal, thereby slowing the progression of the disease.

The treatment is administered every two weeks through an IV infusion, with each session lasting about one hour. Infusions are typically conducted at hospitals and specialized infusion therapy centers. The regular administration schedule ensures that beta-amyloid levels in the brain are consistently managed, providing ongoing therapeutic benefits.

Eligibility and Diagnostic Requirements

The FDA prescribing information specifies that lecanemab is appropriate for individuals with early Alzheimer's disease who have confirmed elevated beta-amyloid levels. This confirmation is crucial, as the therapy has not been tested on individuals with more advanced stages of Alzheimer's or those without clinical symptoms. To diagnose Alzheimer's and confirm the presence of beta-amyloid plaques, physicians use a variety of diagnostic tools, including medical history, mental status tests, physical and neurological exams, biofluid (CSF and blood) tests, and brain imaging techniques such as amyloid PET scans or lumbar punctures (CSF tests).

Before initiating treatment, it is essential for healthcare providers to discuss the potential risks and benefits with patients, including the implications of genetic testing for the ApoE ε4 gene. This gene is a known risk factor for amyloid-related imaging abnormalities (ARIA), a potential side effect of lecanemab. Testing for ApoE ε4 status can help inform the risk of developing ARIA and guide treatment decisions.

Side Effects and Considerations

As with any medication, lecanemab has potential side effects. Commonly reported side effects include infusion-related reactions, amyloid-related imaging abnormalities (ARIA), and headaches. Serious allergic reactions may also occur. It is crucial for patients to have open discussions with their healthcare providers about the risks and benefits of lecanemab to develop a personalized treatment plan. Patients should inform their healthcare providers about all medications and supplements they are taking, especially antithrombotic medicines, including aspirin, to avoid potential interactions.

Cost and Coverage

The manufacturers of lecanemab have set the annual price of the drug at $26,500. Financial assistance is available through the Leqembi Copay Assistance Program, which can be reached at 833.453.7362. The Centers for Medicare & Medicaid Services (CMS) have announced coverage for lecanemab, provided the individual's physician enrolls them in a CMS-approved registry. For those eligible for both Medicare and Medicaid, Medicaid will cover the 20% coinsurance payment, with additional state-level requirements potentially applicable.

Comparative Effectiveness

Lecanemab is part of a class of monoclonal antibodies, including aducanumab (Aduhelm®) and donanemab, that target beta-amyloid in the brain. While these treatments share a common goal, they differ in their mechanisms of action and the stages of plaque formation they target. Lecanemab is not a cure for Alzheimer's but represents a significant advancement in addressing the underlying biology of the disease and slowing its progression in the early stages. By targeting beta-amyloid plaques, lecanemab offers a meaningful way to alter the course of the disease, providing patients with more time to engage in daily activities and maintain their independence.

Global Impact and Future Prospects

Lecanemab's approval marks a significant milestone in the global fight against Alzheimer's disease. As the drug gains approval and becomes available in more countries, its impact on the global Alzheimer's community is expected to grow. Currently, lecanemab is approved in the United States, and efforts are underway to secure approvals in other regions, expanding its accessibility to patients worldwide. The international medical community is closely monitoring the rollout of lecanemab, with many hopeful that it will pave the way for further advancements in Alzheimer's treatment.

Conclusion

Lecanemab (Leqembi®) represents a beacon of hope for individuals with early Alzheimer's disease, offering a promising option to slow cognitive and functional decline. Its ability to target and reduce beta-amyloid in the brain provides patients with more time to engage in daily activities and maintain their independence. As the drug gains approval and becomes available in more countries, its impact on the global fight against Alzheimer's is expected to grow.

The journey of lecanemab from research to approval underscores the importance of continued investment in Alzheimer's research and the development of innovative therapies. While lecanemab is not a cure, it represents a significant step forward in the quest to understand and combat this devastating disease. As research progresses, the hope is that lecanemab will be one of many tools available to clinicians, ultimately leading to more effective treatments and, one day, a cure for Alzheimer's disease.

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